Trial Outcomes & Findings for Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Human Immunodeficiency Virus (HIV)-Positive Adults (NCT NCT01262976)
NCT ID: NCT01262976
Last Updated: 2018-09-17
Results Overview
Solicited local symptoms assessed were pain and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
240 participants
Primary outcome timeframe
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Results posted on
2018-09-17
Participant Flow
Participant milestones
| Measure |
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Up to Month 2
STARTED
|
40
|
40
|
40
|
40
|
40
|
40
|
|
Up to Month 2
COMPLETED
|
37
|
39
|
39
|
38
|
38
|
36
|
|
Up to Month 2
NOT COMPLETED
|
3
|
1
|
1
|
2
|
2
|
4
|
|
Up to Month 7
STARTED
|
40
|
40
|
40
|
40
|
40
|
40
|
|
Up to Month 7
COMPLETED
|
35
|
40
|
34
|
34
|
38
|
36
|
|
Up to Month 7
NOT COMPLETED
|
5
|
0
|
6
|
6
|
2
|
4
|
|
Up to Year 1
STARTED
|
40
|
40
|
40
|
40
|
40
|
40
|
|
Up to Year 1
COMPLETED
|
31
|
39
|
37
|
36
|
29
|
31
|
|
Up to Year 1
NOT COMPLETED
|
9
|
1
|
3
|
4
|
11
|
9
|
|
Up to Year 2
STARTED
|
40
|
40
|
40
|
40
|
40
|
40
|
|
Up to Year 2
COMPLETED
|
35
|
39
|
35
|
36
|
36
|
35
|
|
Up to Year 2
NOT COMPLETED
|
5
|
1
|
5
|
4
|
4
|
5
|
|
Up to Year 3
STARTED
|
40
|
40
|
40
|
40
|
40
|
40
|
|
Up to Year 3
COMPLETED
|
34
|
38
|
33
|
35
|
38
|
36
|
|
Up to Year 3
NOT COMPLETED
|
6
|
2
|
7
|
5
|
2
|
4
|
Reasons for withdrawal
| Measure |
HIV(+)-HA/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/GSK692342
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Up to Month 2
Serious Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Up to Month 2
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Up to Month 2
Migrated/moved from study area
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Up to Month 2
Lost to Follow-up
|
1
|
0
|
0
|
1
|
1
|
1
|
|
Up to Month 2
Other
|
1
|
0
|
0
|
1
|
0
|
2
|
|
Up to Month 7
Serious Adverse Event
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Up to Month 7
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Up to Month 7
Migrated/moved from study area
|
0
|
0
|
1
|
3
|
1
|
1
|
|
Up to Month 7
Lost to Follow-up
|
1
|
0
|
1
|
3
|
1
|
3
|
|
Up to Month 7
Other
|
3
|
0
|
2
|
0
|
0
|
0
|
|
Up to Year 1
Serious Adverse Event
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Up to Year 1
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Up to Year 1
Migrated/moved from study area
|
1
|
0
|
0
|
3
|
3
|
2
|
|
Up to Year 1
Lost to Follow-up
|
4
|
0
|
0
|
1
|
6
|
5
|
|
Up to Year 1
Other
|
3
|
1
|
0
|
0
|
2
|
1
|
|
Up to Year 1
Subjects with unknown completion status
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Up to Year 2
Serious Adverse Event
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Up to Year 2
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Up to Year 2
Migrated/moved from study area
|
0
|
0
|
0
|
2
|
1
|
2
|
|
Up to Year 2
Lost to Follow-up
|
1
|
1
|
2
|
2
|
3
|
3
|
|
Up to Year 2
Subjects with unknown completion status
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Up to Year 2
Other
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Up to Year 3
Serious Adverse Event
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Up to Year 3
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Up to Year 3
Migrated/moved from study area
|
0
|
0
|
0
|
2
|
1
|
1
|
|
Up to Year 3
Lost to Follow-up
|
2
|
2
|
4
|
3
|
1
|
3
|
|
Up to Year 3
Subjects with unknown completion status
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Up to Year 3
Other
|
3
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Human Immunodeficiency Virus (HIV)-Positive Adults
Baseline characteristics by cohort
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)HA-/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
13 Participants
n=10 Participants
|
73 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - Central/South Asian Heritage
|
40 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
38 Participants
n=36 Participants
|
39 Participants
n=10 Participants
|
231 Participants
n=115 Participants
|
|
Age, Continuous
|
36.0 Years
STANDARD_DEVIATION 6.5 • n=93 Participants
|
35.5 Years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
32.6 Years
STANDARD_DEVIATION 6.5 • n=27 Participants
|
32.2 Years
STANDARD_DEVIATION 5.3 • n=483 Participants
|
33.9 Years
STANDARD_DEVIATION 7.6 • n=36 Participants
|
34.6 Years
STANDARD_DEVIATION 6.4 • n=10 Participants
|
34.1 Years
STANDARD_DEVIATION 6.5 • n=115 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
30 Participants
n=36 Participants
|
27 Participants
n=10 Participants
|
167 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - East Asian Heritage
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - South East Asian Heritage
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.
Solicited local symptoms assessed were pain and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.
Solicited general symptoms assessed were fatigue, temperature \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (gastro) \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, malaise and myalgia. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Gastro, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Headache, Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Malaise, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Myalgia, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Temperature, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Gastro, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Headache, Dose 2
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Malaise, Dose 2
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Myalgia, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Temperature, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Fatigue, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Gastro, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Headache, Across doses
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Malaise, Across doses
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Myalgia, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 Solicited General Symptoms
Grade 3 Temperature, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 30-day (Days 0-29) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs)
|
26 Participants
|
27 Participants
|
35 Participants
|
33 Participants
|
13 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: From screening up to one month post Dose 2Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Haematological and biochemical parameters assessed were haemoglobin \[Hgb\], white blood cells \[WBC\], platelets \[PLA\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 3 - Hgb (Decrease)
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 3 - Hgb (Change from baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 4 - Hgb (Change from baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 4 - Hgb (Decrease)
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 3 - WBC (Increase)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 4 - WBC (Increase)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 3 - WBC (Decrease)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 4 - WBC (Decrease)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 3 - PLA
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 4 - PLA
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 3 - ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 4 - ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 3 - AST
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 4 - AST
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 3 - CREA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels
Grade 4 - CREA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Haematological and biochemical parameters assessed were haemoglobin \[Hgb\], white blood cells \[WBC\], platelets \[PLA\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 3 - Hgb (Change from baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 4 - Hgb (Change from baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 3 - Hgb (Decrease)
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 4 - Hgb (Decrease)
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 3 - WBC (Increase)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 4 - WBC (Increase)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 3 - WBC (Decrease)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 4 - WBC (Decrease)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 3 - PLA
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 4 - PLA
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 3 - ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 4 - ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 3 - AST
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 4 - AST
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 3 - CREA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels
Grade 4 - CREA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 30Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Haematological and biochemical parameters assessed were haemoglobin \[Hgb\], white blood cells \[WBC\], platelets \[PLA\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 3 - WBC (Increase)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 4 - WBC (Increase)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 3 - Hgb (Change from baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 4 - Hgb (Change from baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 3 - Hgb (Decrease)
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 4 - Hgb (Decrease)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 3 - WBC (Decrease)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 4 - WBC (Decrease)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 3 - PLA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 4 - PLA
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 3 - ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 4 - ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 3 - AST
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 4 - AST
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 3 - CREA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels
Grade 4 - CREA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 37Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Haematological and biochemical parameters assessed were haemoglobin \[Hgb\], white blood cells \[WBC\], platelets \[PLA\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 3 - Hgb (Change from baseline)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 4 - Hgb (Change from baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 3 - Hgb (Decrease)
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 4 - Hgb (Decrease)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 3 - WBC (Increase)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 4 - WBC (Increase)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 3 - WBC (Decrease)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 4 - WBC (Decrease)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 3 - PLA
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 4 - PLA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 3 - ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 4 - ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 3 - AST
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 4 - AST
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 3 - CREA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological and Biochemical Levels
Grade 4 - CREA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Haematological and biochemical parameters assessed were haemoglobin \[Hgb\], white blood cells \[WBC\], platelets \[PLA\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 4 - Hgb (Change from baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 4 - Hgb (Decrease)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 3 - WBC (Increase)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 4 - WBC (Increase)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 3 - WBC (Decrease)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 4 - WBC (Decrease)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 3 - PLA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 4 - PLA
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 3 - ALT
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 4 - ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 3 - AST
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 4 - AST
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 3 - CREA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 4 - CREA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 3 - Hgb (Change from baseline)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade 3-4 Haematological/Biochemical Levels
Grade 3 - Hgb (Decrease)
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Days 0, 30, 60, 210 and at Years 1, 2 and 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Concentration of M72-specific antibodies, as measured by the enzyme-linked immunosorbent assay (ELISA), were given in ELISA units per milliliter (EU/mL) and expressed as geometric mean concentrations (GMCs).
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=39 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=39 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=39 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=38 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=39 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=39 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Anti-Mycobacterium Tuberculosis Fusion Protein (M72) Specific Antibody Concentrations
Anti-M72, Day 0
|
1.4 EU/mL
Interval 1.4 to 1.4
|
1.4 EU/mL
Interval 1.4 to 1.4
|
1.5 EU/mL
Interval 1.3 to 1.6
|
1.4 EU/mL
Interval 1.4 to 1.4
|
1.4 EU/mL
Interval 1.4 to 1.4
|
1.5 EU/mL
Interval 1.4 to 1.6
|
|
Anti-Mycobacterium Tuberculosis Fusion Protein (M72) Specific Antibody Concentrations
Anti-M72, Day 30
|
4.9 EU/mL
Interval 3.2 to 7.5
|
1.4 EU/mL
Interval 1.4 to 1.4
|
6.0 EU/mL
Interval 4.0 to 9.2
|
1.4 EU/mL
Interval 1.4 to 1.4
|
11.2 EU/mL
Interval 7.5 to 16.7
|
1.5 EU/mL
Interval 1.3 to 1.8
|
|
Anti-Mycobacterium Tuberculosis Fusion Protein (M72) Specific Antibody Concentrations
Anti-M72, Day 60
|
469.3 EU/mL
Interval 310.8 to 708.5
|
1.5 EU/mL
Interval 1.3 to 1.6
|
249.4 EU/mL
Interval 142.3 to 437.2
|
1.4 EU/mL
Interval 1.4 to 1.4
|
754.5 EU/mL
Interval 532.6 to 1068.9
|
1.5 EU/mL
Interval 1.3 to 1.8
|
|
Anti-Mycobacterium Tuberculosis Fusion Protein (M72) Specific Antibody Concentrations
Anti-M72, Day 210
|
45.5 EU/mL
Interval 31.4 to 66.0
|
1.4 EU/mL
Interval 1.4 to 1.4
|
17.7 EU/mL
Interval 11.0 to 28.5
|
1.4 EU/mL
Interval 1.4 to 1.4
|
58.3 EU/mL
Interval 42.2 to 80.6
|
1.5 EU/mL
Interval 1.3 to 1.7
|
|
Anti-Mycobacterium Tuberculosis Fusion Protein (M72) Specific Antibody Concentrations
Anti-M72, Year 1
|
28.0 EU/mL
Interval 18.8 to 41.6
|
1.4 EU/mL
Interval 1.4 to 1.4
|
9.3 EU/mL
Interval 6.3 to 13.8
|
1.4 EU/mL
Interval 1.4 to 1.4
|
29.4 EU/mL
Interval 20.7 to 41.8
|
1.5 EU/mL
Interval 1.3 to 1.6
|
|
Anti-Mycobacterium Tuberculosis Fusion Protein (M72) Specific Antibody Concentrations
Anti-M72, Year 2
|
19.1 EU/mL
Interval 12.9 to 28.1
|
1.4 EU/mL
Interval 1.4 to 1.4
|
5.4 EU/mL
Interval 3.7 to 7.8
|
1.4 EU/mL
Interval 1.4 to 1.4
|
23.9 EU/mL
Interval 17.5 to 32.5
|
1.5 EU/mL
Interval 1.3 to 1.9
|
|
Anti-Mycobacterium Tuberculosis Fusion Protein (M72) Specific Antibody Concentrations
Anti-M72, Year 3
|
22.0 EU/mL
Interval 15.1 to 32.1
|
1.4 EU/mL
Interval 1.4 to 1.4
|
4.9 EU/mL
Interval 3.4 to 7.2
|
1.4 EU/mL
Interval 1.4 to 1.4
|
24.3 EU/mL
Interval 18.4 to 32.1
|
1.5 EU/mL
Interval 1.3 to 1.7
|
SECONDARY outcome
Timeframe: At Days 0, 30, 60, 210 and at Years 1, 2 and 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroconverted subject for M72 antibodies was defined as a seronegative subject at baseline, with the appearance of M72 antibody concentration higher than or equal to (≥) the cut-off value of 2.8 EL.U/mL post vaccination. Antibody concentrations below the cut-off value of the assay were given an arbitrary value of half the cut-off value for the purpose of GMC calculation.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=39 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=39 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=39 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=38 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=39 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=39 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for M72-specific Antibodies
Anti-M72, Day 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Seroconverted Subjects for M72-specific Antibodies
Anti-M72, Day 30
|
23 Participants
|
0 Participants
|
27 Participants
|
0 Participants
|
35 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects for M72-specific Antibodies
Anti-M72, Day 60
|
36 Participants
|
1 Participants
|
37 Participants
|
0 Participants
|
36 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects for M72-specific Antibodies
Anti-M72, Day 210
|
34 Participants
|
0 Participants
|
29 Participants
|
0 Participants
|
36 Participants
|
2 Participants
|
|
Number of Seroconverted Subjects for M72-specific Antibodies
Anti-M72, Year 1
|
30 Participants
|
0 Participants
|
29 Participants
|
0 Participants
|
27 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects for M72-specific Antibodies
Anti-M72, Year 2
|
33 Participants
|
0 Participants
|
24 Participants
|
0 Participants
|
34 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects for M72-specific Antibodies
Anti-M72, Year 3
|
33 Participants
|
0 Participants
|
22 Participants
|
0 Participants
|
36 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Among immune markers expressed after background reduction were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). This endpoint presents results for CD4-all doubles.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=37 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=33 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=35 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=33 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Immune Markers
CD4-all doubles, Day 0
|
176.5 T-cells/million cells
Interval 110.0 to 306.0
|
279.5 T-cells/million cells
Interval 127.0 to 519.0
|
173.0 T-cells/million cells
Interval 63.0 to 300.5
|
145.0 T-cells/million cells
Interval 82.0 to 317.0
|
216.5 T-cells/million cells
Interval 121.0 to 381.0
|
290.0 T-cells/million cells
Interval 122.0 to 489.0
|
|
Frequency of M72-cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Immune Markers
CD4-all doubles, Day 7
|
1253.0 T-cells/million cells
Interval 545.0 to 6993.0
|
278.0 T-cells/million cells
Interval 198.0 to 622.5
|
693.0 T-cells/million cells
Interval 223.0 to 2147.0
|
168.5 T-cells/million cells
Interval 89.5 to 314.5
|
2352.0 T-cells/million cells
Interval 581.0 to 5353.0
|
274.0 T-cells/million cells
Interval 93.0 to 770.0
|
|
Frequency of M72-cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Immune Markers
CD4-all doubles, Day 30
|
1661.0 T-cells/million cells
Interval 992.0 to 2258.0
|
306.0 T-cells/million cells
Interval 143.0 to 621.0
|
610.0 T-cells/million cells
Interval 312.0 to 1654.0
|
163.0 T-cells/million cells
Interval 71.0 to 265.0
|
1499.0 T-cells/million cells
Interval 1021.0 to 2889.0
|
312.0 T-cells/million cells
Interval 147.0 to 524.5
|
|
Frequency of M72-cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Immune Markers
CD4-all doubles, Day 37
|
9060.0 T-cells/million cells
Interval 6906.0 to 15368.0
|
210.0 T-cells/million cells
Interval 138.0 to 512.0
|
5346.5 T-cells/million cells
Interval 2033.0 to 9841.5
|
94.0 T-cells/million cells
Interval 55.0 to 243.0
|
5705.0 T-cells/million cells
Interval 4217.0 to 10980.0
|
204.5 T-cells/million cells
Interval 158.0 to 405.0
|
|
Frequency of M72-cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Immune Markers
CD4-all doubles, Day 60
|
7505.0 T-cells/million cells
Interval 3151.0 to 9705.0
|
230.5 T-cells/million cells
Interval 111.0 to 410.0
|
2283.5 T-cells/million cells
Interval 1618.0 to 4368.0
|
148.5 T-cells/million cells
Interval 91.0 to 244.0
|
2913.0 T-cells/million cells
Interval 1701.5 to 4113.0
|
229.5 T-cells/million cells
Interval 149.0 to 514.0
|
|
Frequency of M72-cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Immune Markers
CD4-all doubles, Day 210
|
3488.0 T-cells/million cells
Interval 2035.0 to 5140.0
|
346.0 T-cells/million cells
Interval 226.0 to 579.5
|
1084.5 T-cells/million cells
Interval 502.0 to 1777.0
|
189.0 T-cells/million cells
Interval 109.0 to 358.0
|
1630.5 T-cells/million cells
Interval 1166.0 to 2400.0
|
287.0 T-cells/million cells
Interval 140.0 to 586.0
|
|
Frequency of M72-cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Immune Markers
CD4-all doubles,Year 1
|
3593.0 T-cells/million cells
Interval 2224.0 to 4827.0
|
373.0 T-cells/million cells
Interval 228.0 to 470.0
|
863.0 T-cells/million cells
Interval 431.0 to 1572.0
|
191.5 T-cells/million cells
Interval 81.5 to 328.0
|
1181.0 T-cells/million cells
Interval 885.0 to 1943.0
|
274.0 T-cells/million cells
Interval 141.0 to 447.5
|
|
Frequency of M72-cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Immune Markers
CD4-all doubles,Year 3
|
3533.0 T-cells/million cells
Interval 1447.5 to 4888.0
|
320.0 T-cells/million cells
Interval 219.0 to 571.0
|
491.0 T-cells/million cells
Interval 208.0 to 1052.0
|
293.0 T-cells/million cells
Interval 187.0 to 677.0
|
1617.0 T-cells/million cells
Interval 1096.0 to 2236.0
|
316.5 T-cells/million cells
Interval 184.0 to 734.0
|
|
Frequency of M72-cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Immune Markers
CD4-all doubles,Year 2
|
2982.0 T-cells/million cells
Interval 1340.0 to 4801.0
|
281.0 T-cells/million cells
Interval 198.0 to 467.0
|
449.0 T-cells/million cells
Interval 204.0 to 884.0
|
141.0 T-cells/million cells
Interval 74.0 to 280.0
|
1364.0 T-cells/million cells
Interval 782.0 to 1964.0
|
261.0 T-cells/million cells
Interval 118.0 to 649.0
|
SECONDARY outcome
Timeframe: At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3Population: The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combinations: CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-),CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+),CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-),CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+).
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=37 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=33 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=35 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=33 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 0
|
58.5 T-cells/million cells
Interval 15.0 to 132.0
|
86.5 T-cells/million cells
Interval 30.5 to 204.5
|
1.0 T-cells/million cells
Interval 1.0 to 65.5
|
23.0 T-cells/million cells
Interval 1.0 to 77.0
|
93.0 T-cells/million cells
Interval 93.0 to 257.5
|
105.0 T-cells/million cells
Interval 19.5 to 240.5
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 7
|
525.0 T-cells/million cells
Interval 153.0 to 1759.0
|
109.5 T-cells/million cells
Interval 60.0 to 210.0
|
165.0 T-cells/million cells
Interval 58.0 to 1029.0
|
1.0 T-cells/million cells
Interval 1.0 to 71.5
|
257.5 T-cells/million cells
Interval 147.0 to 2817.0
|
125.0 T-cells/million cells
Interval 21.0 to 408.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 30
|
307.0 T-cells/million cells
Interval 133.0 to 792.0
|
85.0 T-cells/million cells
Interval 27.0 to 186.0
|
140.0 T-cells/million cells
Interval 25.0 to 816.0
|
1.0 T-cells/million cells
Interval 1.0 to 53.0
|
369.0 T-cells/million cells
Interval 133.0 to 1139.0
|
57.5 T-cells/million cells
Interval 18.5 to 99.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 37
|
2229.0 T-cells/million cells
Interval 1000.0 to 3539.0
|
76.0 T-cells/million cells
Interval 32.0 to 168.0
|
1290.5 T-cells/million cells
Interval 322.0 to 2817.5
|
19.0 T-cells/million cells
Interval 1.0 to 59.0
|
1639.0 T-cells/million cells
Interval 458.0 to 2917.0
|
57.0 T-cells/million cells
Interval 22.0 to 160.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 60
|
1257.0 T-cells/million cells
Interval 428.0 to 2169.0
|
59.5 T-cells/million cells
Interval 17.0 to 158.0
|
616.0 T-cells/million cells
Interval 233.0 to 943.0
|
24.0 T-cells/million cells
Interval 1.0 to 86.0
|
754.0 T-cells/million cells
Interval 320.0 to 1345.5
|
54.0 T-cells/million cells
Interval 27.0 to 107.5
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 210
|
967.0 T-cells/million cells
Interval 435.0 to 1310.0
|
117.5 T-cells/million cells
Interval 44.5 to 278.0
|
380.5 T-cells/million cells
Interval 114.0 to 775.0
|
30.0 T-cells/million cells
Interval 1.0 to 83.0
|
500.0 T-cells/million cells
Interval 307.0 to 884.0
|
106.0 T-cells/million cells
Interval 44.0 to 174.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Year 1
|
798.0 T-cells/million cells
Interval 412.0 to 1586.0
|
102.0 T-cells/million cells
Interval 62.0 to 196.0
|
220.0 T-cells/million cells
Interval 82.0 to 536.0
|
29.0 T-cells/million cells
Interval 1.0 to 92.5
|
410.5 T-cells/million cells
Interval 230.0 to 851.0
|
128.5 T-cells/million cells
Interval 26.0 to 204.5
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Year 2
|
685.0 T-cells/million cells
Interval 285.0 to 1141.0
|
121.0 T-cells/million cells
Interval 58.0 to 283.0
|
155.0 T-cells/million cells
Interval 31.0 to 342.0
|
1.0 T-cells/million cells
Interval 1.0 to 69.0
|
435.0 T-cells/million cells
Interval 308.0 to 853.0
|
88.0 T-cells/million cells
Interval 23.0 to 278.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Year 3
|
1078.0 T-cells/million cells
Interval 584.5 to 1850.0
|
117.5 T-cells/million cells
Interval 75.0 to 319.0
|
158.0 T-cells/million cells
Interval 54.0 to 389.0
|
32.0 T-cells/million cells
Interval 1.0 to 159.0
|
893.0 T-cells/million cells
Interval 456.0 to 1257.0
|
139.0 T-cells/million cells
Interval 72.0 to 347.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Day 30
|
450.0 T-cells/million cells
Interval 296.0 to 698.0
|
26.0 T-cells/million cells
Interval 1.0 to 58.0
|
204.0 T-cells/million cells
Interval 70.0 to 379.0
|
16.0 T-cells/million cells
Interval 1.0 to 46.0
|
463.0 T-cells/million cells
Interval 295.0 to 295.0
|
1.5 T-cells/million cells
Interval 1.0 to 30.5
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Day 210
|
1370.0 T-cells/million cells
Interval 816.0 to 2192.0
|
32.5 T-cells/million cells
Interval 1.0 to 67.5
|
305.5 T-cells/million cells
Interval 161.0 to 678.0
|
1.0 T-cells/million cells
Interval 1.0 to 40.0
|
600.5 T-cells/million cells
Interval 326.0 to 934.0
|
15.0 T-cells/million cells
Interval 1.0 to 31.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Year 1
|
1536.0 T-cells/million cells
Interval 749.0 to 2594.0
|
30.0 T-cells/million cells
Interval 1.0 to 70.0
|
282.0 T-cells/million cells
Interval 139.0 to 589.0
|
1.0 T-cells/million cells
Interval 1.0 to 37.0
|
411.0 T-cells/million cells
Interval 262.0 to 780.0
|
27.5 T-cells/million cells
Interval 1.0 to 55.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Year 2
|
1130.0 T-cells/million cells
Interval 442.0 to 1650.0
|
1.0 T-cells/million cells
Interval 1.0 to 67.0
|
117.0 T-cells/million cells
Interval 40.0 to 421.0
|
18.0 T-cells/million cells
Interval 1.0 to 43.0
|
324.0 T-cells/million cells
Interval 168.0 to 617.0
|
27.0 T-cells/million cells
Interval 1.0 to 59.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Year 3
|
1321.0 T-cells/million cells
Interval 462.0 to 1869.5
|
13.5 T-cells/million cells
Interval 1.0 to 43.0
|
103.0 T-cells/million cells
Interval 39.0 to 356.0
|
32.0 T-cells/million cells
Interval 1.0 to 74.0
|
315.0 T-cells/million cells
Interval 225.0 to 538.0
|
32.5 T-cells/million cells
Interval 1.0 to 71.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 27.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 19.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
1.0 T-cells/million cells
Interval 1.0 to 18.5
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+) IL2(+)+TNFa(-)+IFNg(+), Day 7
|
74.0 T-cells/million cells
Interval 31.0 to 255.0
|
1.0 T-cells/million cells
Interval 1.0 to 23.0
|
65.0 T-cells/million cells
Interval 1.0 to 278.0
|
1.0 T-cells/million cells
Interval 1.0 to 27.0
|
148.0 T-cells/million cells
Interval 25.0 to 413.0
|
1.0 T-cells/million cells
Interval 1.0 to 37.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Day 30
|
63.0 T-cells/million cells
Interval 20.0 to 130.0
|
1.0 T-cells/million cells
Interval 1.0 to 25.0
|
18.0 T-cells/million cells
Interval 1.0 to 43.0
|
1.0 T-cells/million cells
Interval 1.0 to 33.0
|
60.0 T-cells/million cells
Interval 60.0 to 95.0
|
1.0 T-cells/million cells
Interval 1.0 to 25.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Day 37
|
816.0 T-cells/million cells
Interval 364.0 to 1459.0
|
1.0 T-cells/million cells
Interval 1.0 to 25.0
|
507.0 T-cells/million cells
Interval 214.0 to 1184.0
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
546.0 T-cells/million cells
Interval 313.0 to 692.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Day 60
|
325.0 T-cells/million cells
Interval 83.0 to 599.0
|
8.0 T-cells/million cells
Interval 1.0 to 22.0
|
127.0 T-cells/million cells
Interval 67.0 to 226.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
145.5 T-cells/million cells
Interval 80.5 to 219.5
|
5.5 T-cells/million cells
Interval 1.0 to 19.5
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Day 210
|
128.0 T-cells/million cells
Interval 26.0 to 217.0
|
17.0 T-cells/million cells
Interval 1.0 to 32.0
|
8.5 T-cells/million cells
Interval 1.0 to 53.0
|
1.0 T-cells/million cells
Interval 1.0 to 3.0
|
77.5 T-cells/million cells
Interval 29.0 to 138.0
|
1.0 T-cells/million cells
Interval 1.0 to 26.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Year 1
|
160.0 T-cells/million cells
Interval 39.0 to 212.0
|
1.0 T-cells/million cells
Interval 1.0 to 21.0
|
53.0 T-cells/million cells
Interval 1.0 to 49.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
58.0 T-cells/million cells
Interval 1.0 to 100.0
|
1.0 T-cells/million cells
Interval 1.0 to 26.5
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Year 2
|
133.0 T-cells/million cells
Interval 55.0 to 230.0
|
15.0 T-cells/million cells
Interval 1.0 to 36.0
|
20.0 T-cells/million cells
Interval 1.0 to 41.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
57.0 T-cells/million cells
Interval 22.0 to 132.0
|
1.0 T-cells/million cells
Interval 1.0 to 29.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Year 3
|
120.5 T-cells/million cells
Interval 33.0 to 200.5
|
1.0 T-cells/million cells
Interval 1.0 to 24.0
|
1.0 T-cells/million cells
Interval 1.0 to 59.0
|
1.0 T-cells/million cells
Interval 1.0 to 17.0
|
60.0 T-cells/million cells
Interval 29.0 to 86.0
|
14.0 T-cells/million cells
Interval 1.0 to 23.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
1.0 T-cells/million cells
Interval 1.0 to 33.5
|
1.0 T-cells/million cells
Interval 1.0 to 32.0
|
1.0 T-cells/million cells
Interval 1.0 to 30.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.5
|
1.0 T-cells/million cells
Interval 1.0 to 27.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Day 7
|
94.0 T-cells/million cells
Interval 42.0 to 172.0
|
1.0 T-cells/million cells
Interval 1.0 to 26.5
|
51.0 T-cells/million cells
Interval 26.0 to 139.0
|
1.0 T-cells/million cells
Interval 1.0 to 23.5
|
101.0 T-cells/million cells
Interval 27.0 to 252.0
|
1.0 T-cells/million cells
Interval 1.0 to 14.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Day 30
|
351.0 T-cells/million cells
Interval 174.0 to 507.0
|
1.0 T-cells/million cells
Interval 1.0 to 23.0
|
113.0 T-cells/million cells
Interval 13.0 to 180.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
234.0 T-cells/million cells
Interval 92.0 to 554.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Day 37
|
2065.0 T-cells/million cells
Interval 787.0 to 3498.0
|
1.0 T-cells/million cells
Interval 1.0 to 32.0
|
180.0 T-cells/million cells
Interval 316.0 to 1545.0
|
1.0 T-cells/million cells
Interval 1.0 to 28.0
|
1145.0 T-cells/million cells
Interval 591.0 to 1699.0
|
1.0 T-cells/million cells
Interval 1.0 to 21.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Day 210
|
32.0 T-cells/million cells
Interval 1.0 to 83.0
|
8.5 T-cells/million cells
Interval 1.0 to 28.0
|
18.0 T-cells/million cells
Interval 1.0 to 46.0
|
1.0 T-cells/million cells
Interval 1.0 to 36.0
|
31.5 T-cells/million cells
Interval 1.0 to 71.0
|
15.0 T-cells/million cells
Interval 1.0 to 50.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Day 60
|
1591.0 T-cells/million cells
Interval 855.0 to 2307.0
|
1.0 T-cells/million cells
Interval 1.0 to 13.0
|
425.5 T-cells/million cells
Interval 191.0 to 779.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
510.5 T-cells/million cells
Interval 285.5 to 993.0
|
1.0 T-cells/million cells
Interval 1.0 to 42.5
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Day 210
|
476.0 T-cells/million cells
Interval 259.0 to 970.0
|
1.0 T-cells/million cells
Interval 1.0 to 56.5
|
78.0 T-cells/million cells
Interval 6.0 to 225.0
|
1.0 T-cells/million cells
Interval 1.0 to 42.0
|
247.0 T-cells/million cells
Interval 145.0 to 381.0
|
1.0 T-cells/million cells
Interval 1.0 to 41.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Year 1
|
484.0 T-cells/million cells
Interval 309.0 to 722.0
|
1.0 T-cells/million cells
Interval 1.0 to 40.0
|
103.0 T-cells/million cells
Interval 1.0 to 198.0
|
1.0 T-cells/million cells
Interval 1.0 to 13.0
|
185.0 T-cells/million cells
Interval 58.0 to 287.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Year 2
|
526.0 T-cells/million cells
Interval 187.0 to 757.0
|
13.0 T-cells/million cells
Interval 1.0 to 45.0
|
20.5 T-cells/million cells
Interval 1.0 to 97.0
|
1.0 T-cells/million cells
Interval 1.0 to 24.0
|
182.0 T-cells/million cells
Interval 46.0 to 308.0
|
1.0 T-cells/million cells
Interval 1.0 to 17.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Year 3
|
214.0 T-cells/million cells
Interval 58.0 to 633.0
|
1.0 T-cells/million cells
Interval 1.0 to 26.0
|
28.0 T-cells/million cells
Interval 1.0 to 100.0
|
4.0 T-cells/million cells
Interval 1.0 to 48.0
|
94.0 T-cells/million cells
Interval 16.0 to 214.0
|
1.0 T-cells/million cells
Interval 1.0 to 24.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 28.0
|
15.0 T-cells/million cells
Interval 1.0 to 63.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 12.0
|
9.5 T-cells/million cells
Interval 9.5 to 31.0
|
19.0 T-cells/million cells
Interval 1.0 to 49.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Day 7
|
66.0 T-cells/million cells
Interval 23.0 to 486.0
|
1.0 T-cells/million cells
Interval 1.0 to 41.5
|
28.0 T-cells/million cells
Interval 1.0 to 141.0
|
1.0 T-cells/million cells
Interval 1.0 to 26.5
|
117.0 T-cells/million cells
Interval 34.0 to 345.0
|
13.0 T-cells/million cells
Interval 1.0 to 42.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 88.0
|
1.0 T-cells/million cells
Interval 1.0 to 78.0
|
1.0 T-cells/million cells
Interval 1.0 to 68.0
|
1.0 T-cells/million cells
Interval 1.0 to 13.0
|
46.0 T-cells/million cells
Interval 1.0 to 113.0
|
1.0 T-cells/million cells
Interval 1.0 to 33.5
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Day 37
|
391.0 T-cells/million cells
Interval 128.0 to 1004.0
|
1.0 T-cells/million cells
Interval 1.0 to 38.0
|
214.0 T-cells/million cells
Interval 58.5 to 511.5
|
1.0 T-cells/million cells
Interval 1.0 to 2.0
|
318.0 T-cells/million cells
Interval 173.0 to 578.0
|
18.0 T-cells/million cells
Interval 1.0 to 75.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Day 60
|
57.0 T-cells/million cells
Interval 14.0 to 186.0
|
1.0 T-cells/million cells
Interval 1.0 to 45.0
|
28.5 T-cells/million cells
Interval 1.0 to 92.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
76.5 T-cells/million cells
Interval 23.0 to 180.0
|
14.5 T-cells/million cells
Interval 1.0 to 51.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Year 1
|
39.0 T-cells/million cells
Interval 1.0 to 91.0
|
18.0 T-cells/million cells
Interval 1.0 to 44.0
|
1.0 T-cells/million cells
Interval 1.0 to 30.0
|
1.0 T-cells/million cells
Interval 1.0 to 28.0
|
35.0 T-cells/million cells
Interval 15.0 to 85.0
|
1.0 T-cells/million cells
Interval 1.0 to 35.5
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Year 2
|
72.0 T-cells/million cells
Interval 1.0 to 149.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
1.0 T-cells/million cells
Interval 1.0 to 35.0
|
1.0 T-cells/million cells
Interval 1.0 to 36.0
|
29.0 T-cells/million cells
Interval 1.0 to 71.0
|
18.0 T-cells/million cells
Interval 1.0 to 45.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Day 0
|
9.0 T-cells/million cells
Interval 1.0 to 65.0
|
1.5 T-cells/million cells
Interval 1.0 to 40.0
|
1.0 T-cells/million cells
Interval 1.0 to 63.0
|
1.0 T-cells/million cells
Interval 1.0 to 19.0
|
7.0 T-cells/million cells
Interval 1.0 to 37.0
|
14.0 T-cells/million cells
Interval 1.0 to 38.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Day 7
|
110.0 T-cells/million cells
Interval 48.0 to 282.0
|
21.0 T-cells/million cells
Interval 1.0 to 80.5
|
42.0 T-cells/million cells
Interval 1.0 to 226.0
|
1.0 T-cells/million cells
Interval 1.0 to 31.0
|
119.0 T-cells/million cells
Interval 30.0 to 365.0
|
5.0 T-cells/million cells
Interval 1.0 to 34.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Day 37
|
1975.0 T-cells/million cells
Interval 806.0 to 3245.0
|
32.0 T-cells/million cells
Interval 1.0 to 85.0
|
671.5 T-cells/million cells
Interval 383.0 to 1040.0
|
1.0 T-cells/million cells
Interval 1.0 to 21.0
|
937.0 T-cells/million cells
Interval 654.0 to 1458.0
|
2.5 T-cells/million cells
Interval 1.0 to 44.0
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Day 60
|
2162.0 T-cells/million cells
Interval 1039.0 to 4464.0
|
11.0 T-cells/million cells
Interval 1.0 to 59.0
|
788.5 T-cells/million cells
Interval 788.5 to 1184.0
|
1.0 T-cells/million cells
Interval 1.0 to 33.0
|
684.0 T-cells/million cells
Interval 417.5 to 1207.0
|
9.0 T-cells/million cells
Interval 1.0 to 36.5
|
|
Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Year 3
|
38.5 T-cells/million cells
Interval 17.5 to 104.5
|
22.5 T-cells/million cells
Interval 1.0 to 67.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
19.0 T-cells/million cells
Interval 1.0 to 81.0
|
51.0 T-cells/million cells
Interval 21.0 to 98.0
|
14.5 T-cells/million cells
Interval 1.0 to 52.0
|
SECONDARY outcome
Timeframe: At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+),CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-),CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+),CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-)
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=37 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=33 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=35 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=33 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 31.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 47.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
26.0 T-cells/million cells
Interval 16.0 to 86.0
|
1.0 T-cells/million cells
Interval 1.0 to 23.5
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 25.0
|
1.0 T-cells/million cells
Interval 1.0 to 44.0
|
1.0 T-cells/million cells
Interval 1.0 to 42.0
|
1.0 T-cells/million cells
Interval 1.0 to 38.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
14.5 T-cells/million cells
Interval 1.0 to 40.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 7
|
48.0 T-cells/million cells
Interval 1.0 to 134.0
|
1.0 T-cells/million cells
Interval 1.0 to 57.0
|
34.0 T-cells/million cells
Interval 1.0 to 80.0
|
1.0 T-cells/million cells
Interval 1.0 to 26.0
|
34.0 T-cells/million cells
Interval 1.0 to 113.0
|
1.0 T-cells/million cells
Interval 1.0 to 28.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 30
|
54.0 T-cells/million cells
Interval 1.0 to 125.0
|
1.0 T-cells/million cells
Interval 1.0 to 29.0
|
35.0 T-cells/million cells
Interval 1.0 to 72.0
|
1.0 T-cells/million cells
Interval 1.0 to 34.0
|
81.0 T-cells/million cells
Interval 26.0 to 136.0
|
31.5 T-cells/million cells
Interval 1.0 to 73.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 37
|
583.0 T-cells/million cells
Interval 239.0 to 1040.0
|
17.0 T-cells/million cells
Interval 1.0 to 55.0
|
211.5 T-cells/million cells
Interval 69.0 to 456.0
|
1.0 T-cells/million cells
Interval 1.0 to 21.0
|
399.0 T-cells/million cells
Interval 251.0 to 721.0
|
1.0 T-cells/million cells
Interval 1.0 to 37.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Year 1
|
61.0 T-cells/million cells
Interval 14.0 to 141.0
|
1.0 T-cells/million cells
Interval 1.0 to 85.0
|
30.0 T-cells/million cells
Interval 1.0 to 49.0
|
2.0 T-cells/million cells
Interval 1.0 to 42.5
|
43.0 T-cells/million cells
Interval 1.0 to 82.0
|
1.0 T-cells/million cells
Interval 1.0 to 29.5
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Year 2
|
84.0 T-cells/million cells
Interval 2.0 to 110.0
|
17.0 T-cells/million cells
Interval 1.0 to 56.0
|
1.0 T-cells/million cells
Interval 1.0 to 63.0
|
1.0 T-cells/million cells
Interval 1.0 to 50.0
|
40.0 T-cells/million cells
Interval 1.0 to 89.0
|
10.0 T-cells/million cells
Interval 1.0 to 39.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Year 3
|
78.0 T-cells/million cells
Interval 45.0 to 153.5
|
1.0 T-cells/million cells
Interval 1.0 to 53.0
|
25.0 T-cells/million cells
Interval 1.0 to 70.0
|
17.0 T-cells/million cells
Interval 1.0 to 133.0
|
24.0 T-cells/million cells
Interval 1.0 to 106.0
|
8.0 T-cells/million cells
Interval 1.0 to 51.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
4.0 T-cells/million cells
Interval 1.0 to 33.0
|
1.0 T-cells/million cells
Interval 1.0 to 12.5
|
1.0 T-cells/million cells
Interval 1.0 to 32.0
|
1.5 T-cells/million cells
Interval 1.0 to 22.5
|
7.5 T-cells/million cells
Interval 1.0 to 42.5
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Day 7
|
117.0 T-cells/million cells
Interval 24.0 to 209.0
|
1.0 T-cells/million cells
Interval 1.0 to 39.5
|
51.0 T-cells/million cells
Interval 1.0 to 171.0
|
1.0 T-cells/million cells
Interval 1.0 to 32.0
|
84.0 T-cells/million cells
Interval 30.0 to 255.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Day 30
|
21.0 T-cells/million cells
Interval 1.0 to 58.0
|
13.0 T-cells/million cells
Interval 1.0 to 33.0
|
1.0 T-cells/million cells
Interval 1.0 to 49.0
|
1.0 T-cells/million cells
Interval 1.0 to 3.0
|
22.0 T-cells/million cells
Interval 1.0 to 43.0
|
13.5 T-cells/million cells
Interval 1.0 to 29.5
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Day 37
|
725.0 T-cells/million cells
Interval 287.0 to 973.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
388.0 T-cells/million cells
Interval 167.5 to 694.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
740.0 T-cells/million cells
Interval 399.0 to 1129.0
|
8.0 T-cells/million cells
Interval 1.0 to 24.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Day 60
|
74.0 T-cells/million cells
Interval 15.0 to 119.0
|
1.0 T-cells/million cells
Interval 1.0 to 23.0
|
28.5 T-cells/million cells
Interval 1.0 to 44.0
|
1.0 T-cells/million cells
Interval 1.0 to 27.0
|
55.0 T-cells/million cells
Interval 19.5 to 100.0
|
13.5 T-cells/million cells
Interval 1.0 to 45.5
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Day 210
|
26.0 T-cells/million cells
Interval 1.0 to 54.0
|
1.0 T-cells/million cells
Interval 1.0 to 19.0
|
1.0 T-cells/million cells
Interval 1.0 to 22.0
|
1.0 T-cells/million cells
Interval 1.0 to 17.0
|
7.5 T-cells/million cells
Interval 1.0 to 29.0
|
1.0 T-cells/million cells
Interval 1.0 to 18.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Year 1
|
15.0 T-cells/million cells
Interval 1.0 to 46.0
|
1.0 T-cells/million cells
Interval 1.0 to 18.0
|
1.0 T-cells/million cells
Interval 1.0 to 22.0
|
1.0 T-cells/million cells
Interval 1.0 to 11.5
|
13.5 T-cells/million cells
Interval 1.0 to 28.0
|
1.0 T-cells/million cells
Interval 1.0 to 14.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Year 2
|
14.0 T-cells/million cells
Interval 1.0 to 44.0
|
1.0 T-cells/million cells
Interval 1.0 to 18.0
|
1.0 T-cells/million cells
Interval 1.0 to 14.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
15.0 T-cells/million cells
Interval 1.0 to 31.0
|
1.0 T-cells/million cells
Interval 1.0 to 30.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Year 3
|
12.0 T-cells/million cells
Interval 1.0 to 46.5
|
1.0 T-cells/million cells
Interval 1.0 to 27.0
|
1.0 T-cells/million cells
Interval 1.0 to 25.0
|
1.0 T-cells/million cells
Interval 1.0 to 30.0
|
15.0 T-cells/million cells
Interval 1.0 to 43.0
|
1.0 T-cells/million cells
Interval 1.0 to 24.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 150.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 100.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 60.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 270.0
|
1.0 T-cells/million cells
Interval 1.0 to 170.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Day 37
|
1510.0 T-cells/million cells
Interval 510.0 to 3520.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
300.0 T-cells/million cells
Interval 1.0 to 1170.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1400.0 T-cells/million cells
Interval 300.0 to 2330.0
|
1.0 T-cells/million cells
Interval 1.0 to 40.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 1110.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 150.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
1.0 T-cells/million cells
Interval 1.0 to 45.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 5.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 58.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 40.0
|
1.0 T-cells/million cells
Interval 1.0 to 72.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Year 3
|
70.0 T-cells/million cells
Interval 1.0 to 835.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 360.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 230.0
|
1.0 T-cells/million cells
Interval 1.0 to 490.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 17.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 26.5
|
7.0 T-cells/million cells
Interval 1.0 to 38.5
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 176.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
21.0 T-cells/million cells
Interval 1.0 to 119.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
110.0 T-cells/million cells
Interval 1.0 to 245.0
|
1.0 T-cells/million cells
Interval 1.0 to 21.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Day 37
|
38.0 T-cells/million cells
Interval 1.0 to 182.0
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
123.0 T-cells/million cells
Interval 39.0 to 288.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
97.0 T-cells/million cells
Interval 29.0 to 237.0
|
3.0 T-cells/million cells
Interval 1.0 to 20.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Day 60
|
2.0 T-cells/million cells
Interval 1.0 to 39.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
40.5 T-cells/million cells
Interval 1.0 to 96.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
29.0 T-cells/million cells
Interval 12.5 to 45.5
|
1.0 T-cells/million cells
Interval 1.0 to 28.5
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 14.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.5
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 29.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 21.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 21.0
|
1.0 T-cells/million cells
Interval 1.0 to 17.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 13.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 18.0
|
1.0 T-cells/million cells
Interval 1.0 to 7.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 9.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 29.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 44.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 21.0
|
1.0 T-cells/million cells
Interval 1.0 to 11.5
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Day 37
|
43.0 T-cells/million cells
Interval 1.0 to 92.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
36.5 T-cells/million cells
Interval 1.0 to 99.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
19.0 T-cells/million cells
Interval 1.0 to 102.0
|
1.0 T-cells/million cells
Interval 1.0 to 14.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Day 60
|
26.0 T-cells/million cells
Interval 1.0 to 71.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
37.5 T-cells/million cells
Interval 1.0 to 86.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
19.0 T-cells/million cells
Interval 1.0 to 47.5
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 14.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 3.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 60
|
274.0 T-cells/million cells
Interval 50.0 to 542.0
|
1.0 T-cells/million cells
Interval 1.0 to 14.0
|
30.0 T-cells/million cells
Interval 2.0 to 103.0
|
1.0 T-cells/million cells
Interval 1.0 to 30.0
|
85.5 T-cells/million cells
Interval 43.0 to 174.0
|
1.5 T-cells/million cells
Interval 1.0 to 51.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 210
|
48.0 T-cells/million cells
Interval 3.0 to 164.0
|
27.0 T-cells/million cells
Interval 1.0 to 72.5
|
16.5 T-cells/million cells
Interval 1.0 to 112.0
|
1.0 T-cells/million cells
Interval 1.0 to 82.0
|
72.0 T-cells/million cells
Interval 12.0 to 99.0
|
4.0 T-cells/million cells
Interval 1.0 to 57.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
1.0 T-cells/million cells
Interval 1.0 to 9.0
|
SECONDARY outcome
Timeframe: At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-),CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+),CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), CD4.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+).
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=37 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=33 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=35 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=33 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 39.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 33.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
16.0 T-cells/million cells
Interval 1.0 to 56.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 19.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 24.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 23.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 13.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 27.0
|
1.0 T-cells/million cells
Interval 1.0 to 28.0
|
7.5 T-cells/million cells
Interval 1.0 to 43.0
|
17.0 T-cells/million cells
Interval 1.0 to 53.0
|
1.0 T-cells/million cells
Interval 1.0 to 42.5
|
7.0 T-cells/million cells
Interval 1.0 to 33.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Day 30
|
17.0 T-cells/million cells
Interval 1.0 to 57.0
|
1.0 T-cells/million cells
Interval 1.0 to 49.0
|
2.0 T-cells/million cells
Interval 1.0 to 48.0
|
9.0 T-cells/million cells
Interval 1.0 to 55.0
|
20.0 T-cells/million cells
Interval 1.0 to 80.0
|
23.0 T-cells/million cells
Interval 1.0 to 60.5
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Day 37
|
64.0 T-cells/million cells
Interval 1.0 to 151.0
|
1.0 T-cells/million cells
Interval 1.0 to 67.0
|
74.5 T-cells/million cells
Interval 1.0 to 190.5
|
1.0 T-cells/million cells
Interval 1.0 to 25.0
|
60.0 T-cells/million cells
Interval 6.0 to 128.0
|
1.0 T-cells/million cells
Interval 1.0 to 34.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Day 60
|
59.0 T-cells/million cells
Interval 5.0 to 104.0
|
21.5 T-cells/million cells
Interval 1.0 to 89.0
|
25.5 T-cells/million cells
Interval 1.0 to 84.0
|
7.5 T-cells/million cells
Interval 1.0 to 61.0
|
22.0 T-cells/million cells
Interval 1.0 to 73.0
|
1.0 T-cells/million cells
Interval 1.0 to 11.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Day 210
|
14.0 T-cells/million cells
Interval 1.0 to 39.0
|
1.0 T-cells/million cells
Interval 1.0 to 18.5
|
1.0 T-cells/million cells
Interval 1.0 to 21.0
|
1.0 T-cells/million cells
Interval 1.0 to 27.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
1.0 T-cells/million cells
Interval 1.0 to 22.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 30.0
|
1.0 T-cells/million cells
Interval 1.0 to 18.0
|
13.0 T-cells/million cells
Interval 1.0 to 29.0
|
1.0 T-cells/million cells
Interval 1.0 to 41.5
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.5
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Year 2
|
14.0 T-cells/million cells
Interval 1.0 to 34.0
|
1.0 T-cells/million cells
Interval 1.0 to 29.0
|
1.0 T-cells/million cells
Interval 1.0 to 34.0
|
1.0 T-cells/million cells
Interval 1.0 to 58.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
14.0 T-cells/million cells
Interval 1.0 to 31.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 151.0
|
28.5 T-cells/million cells
Interval 1.0 to 189.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
49.0 T-cells/million cells
Interval 1.0 to 166.0
|
21.0 T-cells/million cells
Interval 1.0 to 100.0
|
14.5 T-cells/million cells
Interval 1.0 to 132.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Day 7
|
29.0 T-cells/million cells
Interval 1.0 to 153.0
|
18.0 T-cells/million cells
Interval 1.0 to 62.5
|
28.0 T-cells/million cells
Interval 1.0 to 155.0
|
18.0 T-cells/million cells
Interval 1.0 to 37.0
|
68.0 T-cells/million cells
Interval 16.0 to 146.0
|
11.0 T-cells/million cells
Interval 1.0 to 33.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 75.0
|
13.0 T-cells/million cells
Interval 1.0 to 60.0
|
18.0 T-cells/million cells
Interval 1.0 to 42.0
|
1.0 T-cells/million cells
Interval 1.0 to 35.0
|
17.0 T-cells/million cells
Interval 1.0 to 82.0
|
1.0 T-cells/million cells
Interval 1.0 to 53.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Day 37
|
85.0 T-cells/million cells
Interval 1.0 to 219.0
|
1.0 T-cells/million cells
Interval 1.0 to 22.0
|
80.5 T-cells/million cells
Interval 11.0 to 185.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
56.0 T-cells/million cells
Interval 22.0 to 131.0
|
16.0 T-cells/million cells
Interval 1.0 to 51.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Day 60
|
18.0 T-cells/million cells
Interval 1.0 to 53.0
|
18.0 T-cells/million cells
Interval 1.0 to 51.0
|
1.0 T-cells/million cells
Interval 1.0 to 76.0
|
1.0 T-cells/million cells
Interval 1.0 to 11.0
|
29.5 T-cells/million cells
Interval 1.0 to 42.0
|
1.0 T-cells/million cells
Interval 1.0 to 29.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 30.0
|
1.0 T-cells/million cells
Interval 1.0 to 47.0
|
6.0 T-cells/million cells
Interval 1.0 to 38.0
|
1.0 T-cells/million cells
Interval 1.0 to 42.0
|
1.0 T-cells/million cells
Interval 1.0 to 25.0
|
1.0 T-cells/million cells
Interval 1.0 to 30.5
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 270.0
|
1.0 T-cells/million cells
Interval 1.0 to 195.0
|
1.0 T-cells/million cells
Interval 1.0 to 137.0
|
1.0 T-cells/million cells
Interval 1.0 to 150.0
|
1.0 T-cells/million cells
Interval 1.0 to 71.0
|
1.0 T-cells/million cells
Interval 1.0 to 93.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Day 60
|
2.0 T-cells/million cells
Interval 1.0 to 50.0
|
17.0 T-cells/million cells
Interval 1.0 to 102.0
|
1.0 T-cells/million cells
Interval 1.0 to 35.0
|
1.0 T-cells/million cells
Interval 1.0 to 36.0
|
34.0 T-cells/million cells
Interval 4.0 to 79.5
|
25.0 T-cells/million cells
Interval 1.0 to 68.5
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 58.0
|
1.0 T-cells/million cells
Interval 1.0 to 24.0
|
1.0 T-cells/million cells
Interval 1.0 to 30.0
|
1.0 T-cells/million cells
Interval 1.0 to 35.5
|
7.5 T-cells/million cells
Interval 1.0 to 26.0
|
12.5 T-cells/million cells
Interval 1.0 to 40.5
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 42.0
|
1.0 T-cells/million cells
Interval 1.0 to 22.0
|
18.0 T-cells/million cells
Interval 1.0 to 54.0
|
1.0 T-cells/million cells
Interval 1.0 to 35.0
|
1.0 T-cells/million cells
Interval 1.0 to 51.0
|
1.0 T-cells/million cells
Interval 1.0 to 30.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 590.0
|
1.0 T-cells/million cells
Interval 1.0 to 200.0
|
40.0 T-cells/million cells
Interval 1.0 to 261.0
|
1.0 T-cells/million cells
Interval 1.0 to 150.0
|
48.0 T-cells/million cells
Interval 1.0 to 235.0
|
1.0 T-cells/million cells
Interval 1.0 to 123.5
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Day 37
|
120.0 T-cells/million cells
Interval 1.0 to 423.0
|
1.0 T-cells/million cells
Interval 1.0 to 104.0
|
3.5 T-cells/million cells
Interval 1.0 to 248.5
|
1.0 T-cells/million cells
Interval 1.0 to 36.0
|
320.0 T-cells/million cells
Interval 1.0 to 520.0
|
1.0 T-cells/million cells
Interval 1.0 to 150.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 374.0
|
1.0 T-cells/million cells
Interval 1.0 to 97.0
|
25.5 T-cells/million cells
Interval 1.0 to 228.0
|
1.0 T-cells/million cells
Interval 1.0 to 123.0
|
1.0 T-cells/million cells
Interval 1.0 to 110.5
|
1.0 T-cells/million cells
Interval 1.0 to 166.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Day 210
|
32.0 T-cells/million cells
Interval 1.0 to 192.0
|
118.5 T-cells/million cells
Interval 1.0 to 276.5
|
1.0 T-cells/million cells
Interval 1.0 to 111.0
|
1.0 T-cells/million cells
Interval 1.0 to 196.0
|
37.5 T-cells/million cells
Interval 1.0 to 188.0
|
1.0 T-cells/million cells
Interval 1.0 to 167.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Year 1
|
10.0 T-cells/million cells
Interval 1.0 to 153.0
|
1.0 T-cells/million cells
Interval 1.0 to 140.0
|
7.0 T-cells/million cells
Interval 1.0 to 188.0
|
62.0 T-cells/million cells
Interval 1.0 to 204.5
|
1.0 T-cells/million cells
Interval 1.0 to 95.0
|
62.0 T-cells/million cells
Interval 1.0 to 186.5
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Year 2
|
45.0 T-cells/million cells
Interval 1.0 to 100.0
|
9.0 T-cells/million cells
Interval 1.0 to 67.0
|
1.0 T-cells/million cells
Interval 1.0 to 71.0
|
1.0 T-cells/million cells
Interval 1.0 to 46.0
|
1.0 T-cells/million cells
Interval 1.0 to 26.0
|
1.0 T-cells/million cells
Interval 1.0 to 66.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Year 3
|
8.5 T-cells/million cells
Interval 1.0 to 64.5
|
20.0 T-cells/million cells
Interval 1.0 to 102.0
|
18.0 T-cells/million cells
Interval 1.0 to 80.0
|
44.0 T-cells/million cells
Interval 1.0 to 119.0
|
1.0 T-cells/million cells
Interval 1.0 to 60.0
|
1.0 T-cells/million cells
Interval 1.0 to 96.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Day 0
|
23.0 T-cells/million cells
Interval 1.0 to 97.0
|
2.5 T-cells/million cells
Interval 1.0 to 124.0
|
19.0 T-cells/million cells
Interval 1.0 to 98.0
|
39.0 T-cells/million cells
Interval 1.0 to 85.0
|
36.0 T-cells/million cells
Interval 1.0 to 79.0
|
34.0 T-cells/million cells
Interval 1.0 to 98.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Day 7
|
61.0 T-cells/million cells
Interval 1.0 to 175.0
|
51.5 T-cells/million cells
Interval 1.0 to 97.5
|
15.0 T-cells/million cells
Interval 1.0 to 222.0
|
16.5 T-cells/million cells
Interval 1.0 to 110.5
|
93.0 T-cells/million cells
Interval 58.0 to 188.0
|
18.0 T-cells/million cells
Interval 1.0 to 55.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Day 30
|
61.0 T-cells/million cells
Interval 2.0 to 104.0
|
2.0 T-cells/million cells
Interval 1.0 to 59.0
|
1.0 T-cells/million cells
Interval 1.0 to 44.0
|
40.0 T-cells/million cells
Interval 1.0 to 112.0
|
35.0 T-cells/million cells
Interval 1.0 to 72.0
|
12.5 T-cells/million cells
Interval 1.0 to 76.5
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Day 37
|
135.0 T-cells/million cells
Interval 77.0 to 352.0
|
30.0 T-cells/million cells
Interval 1.0 to 79.0
|
260.0 T-cells/million cells
Interval 116.5 to 471.5
|
1.0 T-cells/million cells
Interval 1.0 to 60.0
|
245.0 T-cells/million cells
Interval 69.0 to 416.0
|
16.0 T-cells/million cells
Interval 1.0 to 63.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Day 210
|
27.0 T-cells/million cells
Interval 1.0 to 61.0
|
16.5 T-cells/million cells
Interval 1.0 to 47.5
|
12.5 T-cells/million cells
Interval 1.0 to 62.0
|
3.0 T-cells/million cells
Interval 1.0 to 37.0
|
2.5 T-cells/million cells
Interval 1.0 to 26.0
|
2.0 T-cells/million cells
Interval 1.0 to 45.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Year 3
|
16.5 T-cells/million cells
Interval 1.0 to 53.0
|
11.0 T-cells/million cells
Interval 1.0 to 51.0
|
31.0 T-cells/million cells
Interval 1.0 to 97.0
|
45.0 T-cells/million cells
Interval 1.0 to 121.0
|
14.0 T-cells/million cells
Interval 1.0 to 57.0
|
25.0 T-cells/million cells
Interval 1.0 to 44.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 37
|
46.0 T-cells/million cells
Interval 1.0 to 112.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
82.0 T-cells/million cells
Interval 32.0 to 177.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
36.0 T-cells/million cells
Interval 14.0 to 78.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Day 7
|
21.0 T-cells/million cells
Interval 1.0 to 90.0
|
11.0 T-cells/million cells
Interval 1.0 to 62.0
|
1.0 T-cells/million cells
Interval 1.0 to 42.0
|
1.0 T-cells/million cells
Interval 1.0 to 38.0
|
3.0 T-cells/million cells
Interval 1.0 to 48.0
|
1.0 T-cells/million cells
Interval 1.0 to 19.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 27.0
|
1.0 T-cells/million cells
Interval 1.0 to 39.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 35.0
|
1.5 T-cells/million cells
Interval 1.0 to 22.0
|
6.0 T-cells/million cells
Interval 1.0 to 30.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 40.0
|
1.0 T-cells/million cells
Interval 1.0 to 51.5
|
1.0 T-cells/million cells
Interval 1.0 to 40.0
|
1.0 T-cells/million cells
Interval 1.0 to 45.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
1.0 T-cells/million cells
Interval 1.0 to 30.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Year 2
|
15.0 T-cells/million cells
Interval 1.0 to 43.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
1.0 T-cells/million cells
Interval 1.0 to 24.0
|
1.0 T-cells/million cells
Interval 1.0 to 14.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
1.0 T-cells/million cells
Interval 1.0 to 30.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Year 3
|
8.0 T-cells/million cells
Interval 1.0 to 74.0
|
1.0 T-cells/million cells
Interval 1.0 to 43.0
|
1.0 T-cells/million cells
Interval 1.0 to 32.0
|
30.0 T-cells/million cells
Interval 1.0 to 72.0
|
1.0 T-cells/million cells
Interval 1.0 to 23.0
|
1.0 T-cells/million cells
Interval 1.0 to 24.0
|
|
M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines
CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Day 0
|
5.5 T-cells/million cells
Interval 1.0 to 240.0
|
1.0 T-cells/million cells
Interval 1.0 to 311.5
|
1.0 T-cells/million cells
Interval 1.0 to 118.5
|
1.0 T-cells/million cells
Interval 1.0 to 30.0
|
1.0 T-cells/million cells
Interval 1.0 to 11.0
|
1.0 T-cells/million cells
Interval 1.0 to 198.5
|
SECONDARY outcome
Timeframe: At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Among immune markers expressed after background reduction were interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for CD8-all doubles.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=37 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=33 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=35 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=33 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-all doubles, Day 37
|
168.0 T-cells/million cells
Interval 92.0 to 599.0
|
45.0 T-cells/million cells
Interval 20.0 to 209.0
|
179.0 T-cells/million cells
Interval 105.5 to 564.0
|
54.0 T-cells/million cells
Interval 16.0 to 146.0
|
157.0 T-cells/million cells
Interval 97.0 to 398.0
|
78.5 T-cells/million cells
Interval 43.0 to 221.0
|
|
Frequency of M72-cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-all doubles, Year 1
|
52.0 T-cells/million cells
Interval 30.0 to 112.0
|
49.0 T-cells/million cells
Interval 11.0 to 165.0
|
47.0 T-cells/million cells
Interval 11.0 to 160.0
|
46.5 T-cells/million cells
Interval 11.0 to 100.0
|
52.0 T-cells/million cells
Interval 11.0 to 115.0
|
58.0 T-cells/million cells
Interval 11.0 to 121.0
|
|
Frequency of M72-cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-all doubles, Day 210
|
82.0 T-cells/million cells
Interval 37.0 to 184.0
|
28.5 T-cells/million cells
Interval 11.0 to 101.0
|
42.0 T-cells/million cells
Interval 18.0 to 197.0
|
55.0 T-cells/million cells
Interval 11.0 to 104.0
|
53.5 T-cells/million cells
Interval 11.0 to 99.0
|
32.0 T-cells/million cells
Interval 11.0 to 103.0
|
|
Frequency of M72-cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-all doubles, Year 2
|
65.0 T-cells/million cells
Interval 34.0 to 131.0
|
42.0 T-cells/million cells
Interval 20.0 to 86.0
|
46.0 T-cells/million cells
Interval 25.0 to 123.0
|
46.0 T-cells/million cells
Interval 26.0 to 90.0
|
40.0 T-cells/million cells
Interval 11.0 to 93.0
|
11.0 T-cells/million cells
Interval 11.0 to 83.0
|
|
Frequency of M72-cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-all doubles, Day 0
|
71.5 T-cells/million cells
Interval 23.0 to 162.0
|
68.5 T-cells/million cells
Interval 31.5 to 182.5
|
58.5 T-cells/million cells
Interval 20.0 to 195.0
|
37.0 T-cells/million cells
Interval 25.0 to 164.0
|
65.0 T-cells/million cells
Interval 31.0 to 115.5
|
84.5 T-cells/million cells
Interval 36.5 to 338.5
|
|
Frequency of M72-cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-all doubles, Day 7
|
224.0 T-cells/million cells
Interval 65.0 to 651.0
|
107.0 T-cells/million cells
Interval 46.0 to 303.5
|
149.0 T-cells/million cells
Interval 49.0 to 486.0
|
71.0 T-cells/million cells
Interval 11.0 to 229.0
|
158.0 T-cells/million cells
Interval 57.0 to 518.0
|
72.0 T-cells/million cells
Interval 39.0 to 241.0
|
|
Frequency of M72-cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-all doubles, Day 30
|
90.0 T-cells/million cells
Interval 41.0 to 311.0
|
85.0 T-cells/million cells
Interval 22.0 to 326.0
|
60.0 T-cells/million cells
Interval 21.0 to 153.0
|
62.0 T-cells/million cells
Interval 11.0 to 129.0
|
56.0 T-cells/million cells
Interval 30.0 to 103.0
|
83.0 T-cells/million cells
Interval 44.0 to 178.0
|
|
Frequency of M72-cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-all doubles, Day 60
|
118.0 T-cells/million cells
Interval 41.0 to 272.0
|
72.5 T-cells/million cells
Interval 24.0 to 231.0
|
91.5 T-cells/million cells
Interval 52.0 to 224.0
|
64.5 T-cells/million cells
Interval 11.0 to 205.0
|
55.0 T-cells/million cells
Interval 11.0 to 117.5
|
135.0 T-cells/million cells
Interval 56.5 to 282.5
|
|
Frequency of M72-cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
CD8-all doubles, Year 3
|
127.5 T-cells/million cells
Interval 43.5 to 347.5
|
41.5 T-cells/million cells
Interval 17.0 to 153.0
|
48.0 T-cells/million cells
Interval 25.0 to 98.0
|
69.0 T-cells/million cells
Interval 27.0 to 120.0
|
94.0 T-cells/million cells
Interval 52.0 to 242.0
|
66.0 T-cells/million cells
Interval 42.0 to 135.0
|
SECONDARY outcome
Timeframe: At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L) interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+),CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-),CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+),CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-),CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+).
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=37 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=33 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=35 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=33 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 21.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Day 37
|
1.0 T-cells/million cells
Interval 1.0 to 19.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
6.0 T-cells/million cells
Interval 1.0 to 39.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 34.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Day 37
|
1.0 T-cells/million cells
Interval 1.0 to 19.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
6.0 T-cells/million cells
Interval 1.0 to 23.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 38.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 7
|
13.0 T-cells/million cells
Interval 1.0 to 143.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 55.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 110.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 37
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
13.0 T-cells/million cells
Interval 1.0 to 58.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 73.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 13.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 32.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Day 37
|
16.0 T-cells/million cells
Interval 1.0 to 33.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 21.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+) IL2(+)+TNFa(-)+IFNg(+), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 11.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 39.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 18.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 37.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Day 37
|
1.0 T-cells/million cells
Interval 1.0 to 26.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 18.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
26.0 T-cells/million cells
Interval 1.0 to 45.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+), Day 7
|
14.0 T-cells/million cells
Interval 1.0 to 61.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 39.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 77.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3Population: The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L) interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-),CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+),CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-),CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+),CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-).
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=37 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=33 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=35 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=33 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 32.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 11.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 62.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Day 37
|
2.0 T-cells/million cells
Interval 1.0 to 29.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
20.0 T-cells/million cells
Interval 1.0 to 49.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
2.0 T-cells/million cells
Interval 1.0 to 89.0
|
1.0 T-cells/million cells
Interval 1.0 to 2.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 13.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 17.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 11.5
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 14.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
1.0 T-cells/million cells
Interval 1.0 to 17.0
|
1.0 T-cells/million cells
Interval 1.0 to 32.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
1.0 T-cells/million cells
Interval 1.0 to 24.0
|
1.0 T-cells/million cells
Interval 1.0 to 36.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 175.0
|
64.5 T-cells/million cells
Interval 1.0 to 199.5
|
155.0 T-cells/million cells
Interval 1.0 to 310.0
|
70.0 T-cells/million cells
Interval 1.0 to 220.0
|
22.0 T-cells/million cells
Interval 1.0 to 211.0
|
1.0 T-cells/million cells
Interval 1.0 to 169.5
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 3.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 11.5
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 14.0
|
1.0 T-cells/million cells
Interval 1.0 to 25.0
|
1.0 T-cells/million cells
Interval 1.0 to 26.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 17.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Day 37
|
1.0 T-cells/million cells
Interval 1.0 to 28.0
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
1.0 T-cells/million cells
Interval 1.0 to 23.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 22.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 13.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 17.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 13.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 22.0
|
1.0 T-cells/million cells
Interval 1.0 to 12.0
|
1.0 T-cells/million cells
Interval 1.0 to 3.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Day 37
|
1.0 T-cells/million cells
Interval 1.0 to 25.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 30.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
2.0 T-cells/million cells
Interval 1.0 to 63.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 14.0
|
1.0 T-cells/million cells
Interval 1.0 to 5.0
|
1.0 T-cells/million cells
Interval 1.0 to 7.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 19.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 14.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Day 7
|
72.0 T-cells/million cells
Interval 1.0 to 235.0
|
25.0 T-cells/million cells
Interval 1.0 to 168.0
|
3.0 T-cells/million cells
Interval 1.0 to 183.0
|
72.0 T-cells/million cells
Interval 1.0 to 218.0
|
74.0 T-cells/million cells
Interval 1.0 to 306.0
|
1.0 T-cells/million cells
Interval 1.0 to 150.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 180.0
|
1.0 T-cells/million cells
Interval 1.0 to 130.0
|
1.0 T-cells/million cells
Interval 1.0 to 112.0
|
47.0 T-cells/million cells
Interval 1.0 to 158.0
|
210.0 T-cells/million cells
Interval 1.0 to 291.0
|
5.5 T-cells/million cells
Interval 1.0 to 128.5
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Day 37
|
146.0 T-cells/million cells
Interval 1.0 to 291.0
|
110.0 T-cells/million cells
Interval 1.0 to 216.0
|
23.0 T-cells/million cells
Interval 1.0 to 252.0
|
20.0 T-cells/million cells
Interval 1.0 to 83.0
|
1.0 T-cells/million cells
Interval 1.0 to 274.0
|
93.0 T-cells/million cells
Interval 1.0 to 272.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 139.0
|
4.0 T-cells/million cells
Interval 1.0 to 128.0
|
1.0 T-cells/million cells
Interval 1.0 to 130.0
|
66.0 T-cells/million cells
Interval 1.0 to 190.0
|
88.5 T-cells/million cells
Interval 1.0 to 223.0
|
1.0 T-cells/million cells
Interval 1.0 to 177.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-), Day 210
|
20.0 T-cells/million cells
Interval 1.0 to 90.0
|
4.0 T-cells/million cells
Interval 1.0 to 77.5
|
1.0 T-cells/million cells
Interval 1.0 to 124.0
|
1.0 T-cells/million cells
Interval 1.0 to 52.0
|
1.0 T-cells/million cells
Interval 1.0 to 141.0
|
1.0 T-cells/million cells
Interval 1.0 to 34.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-),Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 57.0
|
1.0 T-cells/million cells
Interval 1.0 to 94.0
|
1.0 T-cells/million cells
Interval 1.0 to 67.0
|
33.5 T-cells/million cells
Interval 1.0 to 132.5
|
1.0 T-cells/million cells
Interval 1.0 to 44.0
|
1.0 T-cells/million cells
Interval 1.0 to 156.5
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-),Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 42.0
|
1.0 T-cells/million cells
Interval 1.0 to 47.0
|
1.0 T-cells/million cells
Interval 1.0 to 24.0
|
1.0 T-cells/million cells
Interval 1.0 to 90.0
|
18.0 T-cells/million cells
Interval 1.0 to 215.0
|
15.0 T-cells/million cells
Interval 1.0 to 183.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-),Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 82.0
|
1.0 T-cells/million cells
Interval 1.0 to 10.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
1.0 T-cells/million cells
Interval 1.0 to 130.0
|
1.0 T-cells/million cells
Interval 1.0 to 178.0
|
1.0 T-cells/million cells
Interval 1.0 to 109.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 11.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 12.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 13.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Day 37
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L) interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-),CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-),CD8.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+).
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=37 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=34 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=33 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=35 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=33 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 14.0
|
1.0 T-cells/million cells
Interval 1.0 to 8.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
1.0 T-cells/million cells
Interval 1.0 to 9.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 37
|
1.0 T-cells/million cells
Interval 1.0 to 16.0
|
1.0 T-cells/million cells
Interval 1.0 to 11.0
|
1.0 T-cells/million cells
Interval 1.0 to 13.5
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 18.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Day 60
|
1.0 T-cells/million cells
Interval 1.0 to 49.0
|
1.0 T-cells/million cells
Interval 1.0 to 56.0
|
1.0 T-cells/million cells
Interval 1.0 to 49.0
|
1.0 T-cells/million cells
Interval 1.0 to 80.0
|
1.0 T-cells/million cells
Interval 1.0 to 59.5
|
1.0 T-cells/million cells
Interval 1.0 to 64.5
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 5.0
|
1.0 T-cells/million cells
Interval 1.0 to 26.5
|
10.5 T-cells/million cells
Interval 1.0 to 53.0
|
1.0 T-cells/million cells
Interval 1.0 to 46.0
|
59.5 T-cells/million cells
Interval 1.0 to 106.0
|
18.0 T-cells/million cells
Interval 1.0 to 75.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 21.0
|
1.0 T-cells/million cells
Interval 1.0 to 55.0
|
1.0 T-cells/million cells
Interval 1.0 to 50.0
|
1.0 T-cells/million cells
Interval 1.0 to 28.0
|
1.0 T-cells/million cells
Interval 1.0 to 82.0
|
1.0 T-cells/million cells
Interval 1.0 to 28.5
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 56.0
|
16.0 T-cells/million cells
Interval 1.0 to 136.0
|
1.0 T-cells/million cells
Interval 1.0 to 140.0
|
95.0 T-cells/million cells
Interval 1.0 to 209.0
|
1.0 T-cells/million cells
Interval 1.0 to 315.0
|
1.0 T-cells/million cells
Interval 1.0 to 92.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Day 0
|
35.5 T-cells/million cells
Interval 1.0 to 135.0
|
34.0 T-cells/million cells
Interval 1.0 to 90.5
|
33.0 T-cells/million cells
Interval 1.0 to 137.5
|
21.0 T-cells/million cells
Interval 1.0 to 144.0
|
9.5 T-cells/million cells
Interval 1.0 to 88.0
|
68.0 T-cells/million cells
Interval 1.0 to 316.5
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Day 30
|
1.0 T-cells/million cells
Interval 1.0 to 186.0
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
16.0 T-cells/million cells
Interval 1.0 to 97.0
|
1.0 T-cells/million cells
Interval 1.0 to 47.0
|
1.0 T-cells/million cells
Interval 1.0 to 60.0
|
17.5 T-cells/million cells
Interval 1.0 to 121.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Day 210
|
1.0 T-cells/million cells
Interval 1.0 to 37.0
|
1.0 T-cells/million cells
Interval 1.0 to 38.0
|
35.5 T-cells/million cells
Interval 1.0 to 118.0
|
1.0 T-cells/million cells
Interval 1.0 to 55.0
|
1.0 T-cells/million cells
Interval 1.0 to 60.0
|
28.0 T-cells/million cells
Interval 1.0 to 90.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Year 3
|
70.5 T-cells/million cells
Interval 11.0 to 219.5
|
1.0 T-cells/million cells
Interval 1.0 to 95.0
|
73.0 T-cells/million cells
Interval 1.0 to 226.0
|
44.0 T-cells/million cells
Interval 1.0 to 162.0
|
1.0 T-cells/million cells
Interval 1.0 to 114.0
|
41.0 T-cells/million cells
Interval 1.0 to 100.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Day 37
|
59.0 T-cells/million cells
Interval 1.0 to 167.0
|
18.0 T-cells/million cells
Interval 1.0 to 157.0
|
62.5 T-cells/million cells
Interval 9.0 to 124.5
|
24.0 T-cells/million cells
Interval 1.0 to 117.0
|
23.0 T-cells/million cells
Interval 1.0 to 48.0
|
22.5 T-cells/million cells
Interval 1.0 to 186.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 14.0
|
1.0 T-cells/million cells
Interval 1.0 to 12.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 12.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 20.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 15.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Day 0
|
3.5 T-cells/million cells
Interval 1.0 to 59.0
|
1.0 T-cells/million cells
Interval 1.0 to 62.5
|
1.0 T-cells/million cells
Interval 1.0 to 5.5
|
1.0 T-cells/million cells
Interval 1.0 to 32.0
|
28.5 T-cells/million cells
Interval 1.0 to 127.5
|
1.0 T-cells/million cells
Interval 1.0 to 50.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 64.0
|
17.5 T-cells/million cells
Interval 1.0 to 64.5
|
41.0 T-cells/million cells
Interval 1.0 to 87.0
|
10.5 T-cells/million cells
Interval 1.0 to 66.5
|
56.0 T-cells/million cells
Interval 1.0 to 105.0
|
1.0 T-cells/million cells
Interval 1.0 to 65.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Day 30
|
52.0 T-cells/million cells
Interval 1.0 to 162.0
|
1.0 T-cells/million cells
Interval 1.0 to 66.0
|
13.0 T-cells/million cells
Interval 1.0 to 46.0
|
1.0 T-cells/million cells
Interval 1.0 to 85.0
|
1.0 T-cells/million cells
Interval 1.0 to 128.0
|
5.0 T-cells/million cells
Interval 1.0 to 106.5
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Day 60
|
33.0 T-cells/million cells
Interval 1.0 to 181.0
|
38.0 T-cells/million cells
Interval 1.0 to 135.0
|
44.5 T-cells/million cells
Interval 1.0 to 192.0
|
32.5 T-cells/million cells
Interval 1.0 to 179.0
|
1.0 T-cells/million cells
Interval 1.0 to 11.5
|
72.0 T-cells/million cells
Interval 1.0 to 211.5
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Day 37
|
1.0 T-cells/million cells
Interval 1.0 to 84.0
|
1.0 T-cells/million cells
Interval 1.0 to 67.0
|
1.0 T-cells/million cells
Interval 1.0 to 65.0
|
1.0 T-cells/million cells
Interval 1.0 to 76.0
|
31.0 T-cells/million cells
Interval 1.0 to 163.0
|
1.0 T-cells/million cells
Interval 1.0 to 23.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-), Year 2
|
1.0 T-cells/million cells
Interval 1.0 to 7.0
|
3.0 T-cells/million cells
Interval 1.0 to 52.0
|
7.5 T-cells/million cells
Interval 1.0 to 85.0
|
1.0 T-cells/million cells
Interval 1.0 to 26.0
|
1.0 T-cells/million cells
Interval 1.0 to 63.0
|
22.0 T-cells/million cells
Interval 1.0 to 76.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Day 7
|
41.0 T-cells/million cells
Interval 1.0 to 139.0
|
74.0 T-cells/million cells
Interval 1.0 to 238.5
|
27.0 T-cells/million cells
Interval 1.0 to 147.0
|
23.5 T-cells/million cells
Interval 1.0 to 135.5
|
1.0 T-cells/million cells
Interval 1.0 to 54.0
|
35.0 T-cells/million cells
Interval 1.0 to 168.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Day 30
|
40.0 T-cells/million cells
Interval 1.0 to 161.0
|
26.0 T-cells/million cells
Interval 1.0 to 189.0
|
9.0 T-cells/million cells
Interval 1.0 to 127.0
|
27.0 T-cells/million cells
Interval 1.0 to 86.0
|
1.0 T-cells/million cells
Interval 1.0 to 29.0
|
52.0 T-cells/million cells
Interval 1.0 to 148.5
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Day 210
|
36.0 T-cells/million cells
Interval 1.0 to 127.0
|
1.0 T-cells/million cells
Interval 1.0 to 67.5
|
15.5 T-cells/million cells
Interval 1.0 to 150.0
|
8.0 T-cells/million cells
Interval 1.0 to 72.0
|
1.0 T-cells/million cells
Interval 1.0 to 53.0
|
1.0 T-cells/million cells
Interval 1.0 to 61.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Year 1
|
13.0 T-cells/million cells
Interval 1.0 to 59.0
|
31.0 T-cells/million cells
Interval 1.0 to 155.0
|
25.0 T-cells/million cells
Interval 1.0 to 150.0
|
1.0 T-cells/million cells
Interval 1.0 to 70.0
|
1.0 T-cells/million cells
Interval 1.0 to 53.0
|
1.0 T-cells/million cells
Interval 1.0 to 79.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Year 2
|
20.0 T-cells/million cells
Interval 1.0 to 84.0
|
20.0 T-cells/million cells
Interval 1.0 to 54.0
|
26.5 T-cells/million cells
Interval 1.0 to 105.0
|
19.0 T-cells/million cells
Interval 1.0 to 67.0
|
1.0 T-cells/million cells
Interval 1.0 to 53.0
|
1.0 T-cells/million cells
Interval 1.0 to 46.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), Year 3
|
60.0 T-cells/million cells
Interval 1.0 to 209.0
|
1.0 T-cells/million cells
Interval 1.0 to 119.0
|
1.0 T-cells/million cells
Interval 1.0 to 52.0
|
11.0 T-cells/million cells
Interval 1.0 to 105.0
|
57.0 T-cells/million cells
Interval 1.0 to 145.0
|
33.0 T-cells/million cells
Interval 1.0 to 55.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Day 0
|
1.0 T-cells/million cells
Interval 1.0 to 123.0
|
1.0 T-cells/million cells
Interval 1.0 to 39.0
|
1.0 T-cells/million cells
Interval 1.0 to 42.5
|
1.0 T-cells/million cells
Interval 1.0 to 47.0
|
1.0 T-cells/million cells
Interval 1.0 to 52.0
|
1.0 T-cells/million cells
Interval 1.0 to 81.5
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Day 7
|
1.0 T-cells/million cells
Interval 1.0 to 101.0
|
27.0 T-cells/million cells
Interval 1.0 to 96.5
|
29.0 T-cells/million cells
Interval 1.0 to 150.5
|
1.0 T-cells/million cells
Interval 1.0 to 30.0
|
1.0 T-cells/million cells
Interval 1.0 to 63.0
|
1.0 T-cells/million cells
Interval 1.0 to 56.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Day 37
|
1.0 T-cells/million cells
Interval 1.0 to 169.0
|
1.0 T-cells/million cells
Interval 1.0 to 42.0
|
1.5 T-cells/million cells
Interval 1.0 to 92.0
|
1.0 T-cells/million cells
Interval 1.0 to 49.0
|
33.0 T-cells/million cells
Interval 1.0 to 148.0
|
19.0 T-cells/million cells
Interval 1.0 to 92.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Day 60
|
4.0 T-cells/million cells
Interval 1.0 to 99.0
|
1.0 T-cells/million cells
Interval 1.0 to 1.0
|
20.0 T-cells/million cells
Interval 1.0 to 69.0
|
1.0 T-cells/million cells
Interval 1.0 to 41.0
|
1.0 T-cells/million cells
Interval 1.0 to 35.5
|
16.5 T-cells/million cells
Interval 1.0 to 113.5
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Year 1
|
1.0 T-cells/million cells
Interval 1.0 to 71.0
|
1.0 T-cells/million cells
Interval 1.0 to 41.0
|
18.0 T-cells/million cells
Interval 1.0 to 70.0
|
1.0 T-cells/million cells
Interval 1.0 to 25.0
|
1.0 T-cells/million cells
Interval 1.0 to 54.0
|
1.0 T-cells/million cells
Interval 1.0 to 66.5
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Year 2
|
36.0 T-cells/million cells
Interval 1.0 to 111.0
|
12.0 T-cells/million cells
Interval 1.0 to 52.0
|
32.5 T-cells/million cells
Interval 1.0 to 108.0
|
1.0 T-cells/million cells
Interval 1.0 to 61.0
|
3.0 T-cells/million cells
Interval 1.0 to 55.0
|
1.0 T-cells/million cells
Interval 1.0 to 46.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), Year 3
|
1.0 T-cells/million cells
Interval 1.0 to 157.5
|
7.5 T-cells/million cells
Interval 1.0 to 156.0
|
1.0 T-cells/million cells
Interval 1.0 to 51.0
|
1.0 T-cells/million cells
Interval 1.0 to 95.0
|
1.0 T-cells/million cells
Interval 1.0 to 79.0
|
27.5 T-cells/million cells
Interval 1.0 to 129.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Day 0
|
35.5 T-cells/million cells
Interval 1.0 to 416.0
|
71.0 T-cells/million cells
Interval 1.0 to 247.0
|
47.5 T-cells/million cells
Interval 1.0 to 220.0
|
50.0 T-cells/million cells
Interval 1.0 to 175.0
|
1.0 T-cells/million cells
Interval 1.0 to 98.5
|
112.5 T-cells/million cells
Interval 1.0 to 408.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Day 7
|
38.0 T-cells/million cells
Interval 1.0 to 249.0
|
108.5 T-cells/million cells
Interval 1.0 to 243.5
|
30.0 T-cells/million cells
Interval 1.0 to 200.0
|
61.0 T-cells/million cells
Interval 22.0 to 165.5
|
51.0 T-cells/million cells
Interval 1.0 to 203.0
|
128.0 T-cells/million cells
Interval 21.0 to 294.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Day 30
|
67.0 T-cells/million cells
Interval 1.0 to 411.0
|
50.0 T-cells/million cells
Interval 1.0 to 317.0
|
37.0 T-cells/million cells
Interval 1.0 to 94.0
|
37.0 T-cells/million cells
Interval 1.0 to 195.0
|
8.0 T-cells/million cells
Interval 1.0 to 83.0
|
93.5 T-cells/million cells
Interval 9.5 to 286.5
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Day 37
|
65.0 T-cells/million cells
Interval 1.0 to 369.0
|
19.0 T-cells/million cells
Interval 1.0 to 134.0
|
55.0 T-cells/million cells
Interval 7.5 to 141.5
|
24.0 T-cells/million cells
Interval 1.0 to 161.0
|
29.0 T-cells/million cells
Interval 1.0 to 116.0
|
116.0 T-cells/million cells
Interval 1.0 to 268.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Day 60
|
49.0 T-cells/million cells
Interval 1.0 to 203.0
|
144.5 T-cells/million cells
Interval 1.0 to 354.0
|
58.5 T-cells/million cells
Interval 1.0 to 133.0
|
75.5 T-cells/million cells
Interval 1.0 to 207.0
|
25.5 T-cells/million cells
Interval 1.0 to 134.0
|
119.5 T-cells/million cells
Interval 1.0 to 275.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Day 210
|
79.0 T-cells/million cells
Interval 1.0 to 246.0
|
1.0 T-cells/million cells
Interval 1.0 to 70.0
|
84.5 T-cells/million cells
Interval 1.0 to 221.0
|
1.0 T-cells/million cells
Interval 1.0 to 54.0
|
40.5 T-cells/million cells
Interval 1.0 to 142.0
|
30.0 T-cells/million cells
Interval 1.0 to 150.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Year 1
|
29.0 T-cells/million cells
Interval 1.0 to 121.0
|
46.0 T-cells/million cells
Interval 1.0 to 108.0
|
33.0 T-cells/million cells
Interval 1.0 to 542.0
|
33.0 T-cells/million cells
Interval 1.0 to 117.0
|
50.0 T-cells/million cells
Interval 1.0 to 110.0
|
1.5 T-cells/million cells
Interval 1.0 to 169.0
|
|
M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines
CD8.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+), Year 2
|
37.0 T-cells/million cells
Interval 1.0 to 143.0
|
43.0 T-cells/million cells
Interval 1.0 to 173.0
|
43.5 T-cells/million cells
Interval 1.0 to 218.0
|
6.0 T-cells/million cells
Interval 1.0 to 66.0
|
29.0 T-cells/million cells
Interval 1.0 to 111.0
|
3.0 T-cells/million cells
Interval 1.0 to 93.0
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in their symptom sheets.
Solicited local symptoms assessed were pain and swelling. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Solicited Local Symptoms
Any Pain, Dose 1
|
12 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
8 Participants
|
3 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Swelling, Dose 1
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Pain, Dose 2
|
10 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
7 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Swelling, Dose 2
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Pain, Across doses
|
14 Participants
|
7 Participants
|
8 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Swelling, Across doses
|
5 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in their symptom sheets.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (Gastro), headache, malaise, myalgia and temperature. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Solicited General Symptoms
Any Headache, Dose 1
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Temperature, Across doses
|
5 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
9 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Fatigue, Dose 1
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Gastro, Dose 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Malaise, Dose 1
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Myalgia, Dose 1
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Temperature, Dose 1
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Fatigue, Dose 2
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Gastro, Dose 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Headache, Dose 2
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
8 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Malaise, Dose 2
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Myalgia, Dose 2
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Temperature, Dose 2
|
5 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
9 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Fatigue, Across doses
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Gastro, Across doses
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Headache, Across doses
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Malaise, Across doses
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Myalgia, Across doses
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 30-day (Days 0-29) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited AEs
|
26 Participants
|
27 Participants
|
35 Participants
|
33 Participants
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: From one month post Dose 2 up to study end (Year 3)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With SAEs
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Days 0, 7, 30, 37 and 60Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Biochemical and haematological parameters included haemoglobin \[Hgb\], white blood cells \[WBC\], platelets \[PLA\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. Levels assessed were - normal, grade 1, grade 2 and missing grade. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Outcome measures
| Measure |
HIV(+)-HA/GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/ GSK692342
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 Participants
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 Participants
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - Hgb (Change from baseline), Day 0
|
21 Participants
|
11 Participants
|
14 Participants
|
12 Participants
|
19 Participants
|
17 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - Hgb (Change from baseline), Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - Hgb (Change from baseline), Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - Hgb (Change from baseline), Day 30
|
17 Participants
|
24 Participants
|
22 Participants
|
25 Participants
|
20 Participants
|
23 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - Hgb (Change from baseline), Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - Hgb (Decrease), Day 7
|
7 Participants
|
11 Participants
|
11 Participants
|
7 Participants
|
9 Participants
|
11 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - PLA, Day 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - Hgb (Decrease), Day 60
|
9 Participants
|
10 Participants
|
13 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - Hgb (Decrease), Day 60
|
2 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - WBC (Increase), Day 30
|
35 Participants
|
40 Participants
|
38 Participants
|
40 Participants
|
39 Participants
|
34 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - WBC (Decrease), Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - WBC (Decrease), Day 30
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - WBC (Decrease), Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - WBC (Decrease), Day 37
|
35 Participants
|
38 Participants
|
39 Participants
|
39 Participants
|
39 Participants
|
37 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - WBC (Decrease), Day 37
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - WBC (Decrease), Day 60
|
36 Participants
|
38 Participants
|
39 Participants
|
38 Participants
|
38 Participants
|
35 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - WBC (Decrease), Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - PLA, Day 0
|
40 Participants
|
39 Participants
|
38 Participants
|
40 Participants
|
40 Participants
|
40 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - PLA, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - PLA, Day 30
|
39 Participants
|
40 Participants
|
39 Participants
|
40 Participants
|
39 Participants
|
38 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - ALT, Day 0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - CREA, Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - CREA, Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - CREA, Day 30
|
38 Participants
|
40 Participants
|
40 Participants
|
40 Participants
|
39 Participants
|
38 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - CREA, Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - Hgb (Change from baseline), Day 0
|
19 Participants
|
28 Participants
|
26 Participants
|
27 Participants
|
21 Participants
|
23 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - Hgb (Change from baseline), Day 0
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - Hgb (Change from baseline), Day 7
|
20 Participants
|
24 Participants
|
26 Participants
|
25 Participants
|
17 Participants
|
21 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - Hgb (Change from baseline), Day 7
|
20 Participants
|
15 Participants
|
14 Participants
|
13 Participants
|
22 Participants
|
17 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - Hgb (Change from baseline), Day 7
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - Hgb (Change from baseline), Day 30
|
21 Participants
|
15 Participants
|
16 Participants
|
15 Participants
|
19 Participants
|
14 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - Hgb (Change from baseline), Day 30
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - PLA, Day 7
|
40 Participants
|
39 Participants
|
39 Participants
|
39 Participants
|
39 Participants
|
40 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - Hgb (Change from baseline), Day 37
|
15 Participants
|
23 Participants
|
20 Participants
|
26 Participants
|
17 Participants
|
17 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - Hgb (Decrease), Day 30
|
4 Participants
|
3 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - Hgb (Change from baseline), Day 37
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - Hgb (Change from baseline), Day 37
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - Hgb (Change from baseline), Day 60
|
21 Participants
|
26 Participants
|
26 Participants
|
26 Participants
|
19 Participants
|
18 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - Hgb (Decrease), Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - Hgb (Change from baseline), Day 37
|
22 Participants
|
15 Participants
|
16 Participants
|
12 Participants
|
21 Participants
|
19 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - Hgb (Change from baseline), Day 60
|
15 Participants
|
12 Participants
|
12 Participants
|
10 Participants
|
19 Participants
|
17 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - Hgb (Change from baseline), Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - Hgb (Change from baseline), Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - Hgb (Decrease), Day 0
|
28 Participants
|
25 Participants
|
19 Participants
|
25 Participants
|
23 Participants
|
22 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - Hgb (Decrease), Day 0
|
6 Participants
|
11 Participants
|
9 Participants
|
3 Participants
|
10 Participants
|
13 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - Hgb (Decrease), Day 37
|
22 Participants
|
24 Participants
|
16 Participants
|
17 Participants
|
20 Participants
|
21 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - PLA, Day 37
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - PLA Day 37
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - PLA, Day 60
|
37 Participants
|
38 Participants
|
38 Participants
|
38 Participants
|
38 Participants
|
35 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - PLA, Day 60
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - PLA, Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - PLA, Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - Hgb (Decrease), Day 0
|
3 Participants
|
3 Participants
|
9 Participants
|
9 Participants
|
5 Participants
|
3 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - Hgb (Decrease), Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - Hgb (Decrease), Day 7
|
27 Participants
|
24 Participants
|
19 Participants
|
21 Participants
|
22 Participants
|
22 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - Hgb (Decrease), Day 7
|
3 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - Hgb (Decrease), Day 37
|
9 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
10 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - Hgb (Decrease), Day 37
|
4 Participants
|
2 Participants
|
9 Participants
|
8 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - Hgb (Decrease), Day 37
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - Hgb (Decrease), Day 60
|
24 Participants
|
25 Participants
|
17 Participants
|
21 Participants
|
22 Participants
|
21 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - Hgb (Decrease), Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - WBC (Increase), Day 0
|
39 Participants
|
37 Participants
|
38 Participants
|
37 Participants
|
35 Participants
|
36 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - WBC (Increase), Day 0
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - WBC (Increase), Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - WBC (Increase), Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - WBC (Increase), Day 7
|
38 Participants
|
38 Participants
|
38 Participants
|
37 Participants
|
36 Participants
|
37 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - WBC (Increase), Day 7
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - WBC (Increase), Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - WBC (Increase), Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - WBC (Increase), Day 30
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - WBC (Increase), Day 30
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - WBC (Increase), Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - WBC (Increase), Day 37
|
34 Participants
|
36 Participants
|
38 Participants
|
35 Participants
|
35 Participants
|
32 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - ALT, Day 0
|
33 Participants
|
34 Participants
|
38 Participants
|
35 Participants
|
38 Participants
|
37 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - WBC (Increase), Day 37
|
4 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - WBC (Increase), Day 37
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - WBC (Increase), Day 37
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - WBC (Increase), Day 60
|
34 Participants
|
38 Participants
|
37 Participants
|
35 Participants
|
34 Participants
|
29 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - ALT, Day 0
|
6 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - WBC (Increase), Day 60
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - WBC (Increase), Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - WBC (Increase), Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - WBC (Decrease), Day 0
|
40 Participants
|
39 Participants
|
40 Participants
|
40 Participants
|
40 Participants
|
40 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - WBC (Decrease), Day 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - WBC (Decrease), Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - WBC (Decrease), Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - ALT, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - WBC (Decrease), Day 7
|
39 Participants
|
40 Participants
|
40 Participants
|
39 Participants
|
39 Participants
|
40 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - WBC (Decrease), Day 7
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - WBC (Decrease), Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - WBC (Decrease), Day 30
|
38 Participants
|
39 Participants
|
40 Participants
|
40 Participants
|
39 Participants
|
38 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - ALT, Day 7
|
30 Participants
|
32 Participants
|
34 Participants
|
34 Participants
|
35 Participants
|
35 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - ALT, Day 7
|
9 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - ALT, Day 7
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - ALT, Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - ALT, Day 30
|
30 Participants
|
34 Participants
|
35 Participants
|
36 Participants
|
36 Participants
|
35 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - ALT, Day 30
|
9 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - ALT, Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - ALT, Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - ALT, Day 37
|
28 Participants
|
33 Participants
|
37 Participants
|
35 Participants
|
35 Participants
|
35 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - ALT, Day 37
|
9 Participants
|
6 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - ALT, Day 37
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - ALT, Day 37
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - ALT, Day 60
|
30 Participants
|
32 Participants
|
34 Participants
|
34 Participants
|
35 Participants
|
33 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - ALT, Day 60
|
6 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - ALT, Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - ALT, Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - AST, Day 0
|
34 Participants
|
31 Participants
|
35 Participants
|
30 Participants
|
37 Participants
|
38 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - WBC (Decrease), Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - AST, Day 0
|
5 Participants
|
9 Participants
|
5 Participants
|
10 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - AST, Day 0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - AST, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - AST, Day 7
|
33 Participants
|
30 Participants
|
32 Participants
|
30 Participants
|
33 Participants
|
36 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - AST, Day 7
|
6 Participants
|
10 Participants
|
7 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - AST, Day 7
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - AST, Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - AST, Day 30
|
32 Participants
|
33 Participants
|
33 Participants
|
30 Participants
|
33 Participants
|
35 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - AST, Day 30
|
6 Participants
|
7 Participants
|
7 Participants
|
9 Participants
|
5 Participants
|
3 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - AST, Day 30
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - AST, Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - AST, Day 37
|
29 Participants
|
32 Participants
|
30 Participants
|
29 Participants
|
35 Participants
|
36 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - AST, Day 37
|
8 Participants
|
7 Participants
|
9 Participants
|
11 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - AST, Day 37
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - AST, Day 37
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - AST, Day 60
|
28 Participants
|
31 Participants
|
27 Participants
|
27 Participants
|
33 Participants
|
30 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - AST, Day 60
|
8 Participants
|
7 Participants
|
12 Participants
|
11 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - AST, Day 60
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - AST, Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - CREA, Day 0
|
39 Participants
|
40 Participants
|
40 Participants
|
40 Participants
|
40 Participants
|
40 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - CREA, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - WBC (Decrease), Day 37
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - WBC (Decrease), Day 37
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - CREA, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - CREA, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - CREA, Day 7
|
39 Participants
|
40 Participants
|
40 Participants
|
39 Participants
|
38 Participants
|
40 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - CREA, Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - CREA, Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - CREA, Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - CREA, Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - CREA, Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - CREA, Day 37
|
37 Participants
|
39 Participants
|
39 Participants
|
40 Participants
|
39 Participants
|
37 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - CREA, Day 37
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - CREA, Day 37
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - WBC (Decrease), Day 60
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - CREA, Day 37
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - CREA, Day 60
|
36 Participants
|
39 Participants
|
39 Participants
|
38 Participants
|
38 Participants
|
35 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - WBC (Decrease), Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - CREA, Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - PLA, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - PLA, Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - PLA, Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - PLA, Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - Hgb (Decrease), Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - Hgb (Decrease), Day 30
|
23 Participants
|
22 Participants
|
17 Participants
|
22 Participants
|
21 Participants
|
22 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - PLA, Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 2 - PLA, Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - Hgb (Decrease), Day 30
|
9 Participants
|
15 Participants
|
10 Participants
|
7 Participants
|
10 Participants
|
12 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Missing - PLA, Day 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Normal - PLA, Day 37
|
38 Participants
|
38 Participants
|
38 Participants
|
39 Participants
|
38 Participants
|
37 Participants
|
|
Number of Subjects Presenting Different Grades of Haematological and Biochemical Values
Grade 1 - PLA, Day 37
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
HIV(+)-HA/GSK692342
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
HIV(+)-HA/Placebo
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
HIV(+)-TN/GSK692342
Serious events: 3 serious events
Other events: 33 other events
Deaths: 2 deaths
HIV(+)-TN/Placebo
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
HIV(-)/GSK692342
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
HIV(-)/Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV(+)-HA/GSK692342
n=40 participants at risk
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 participants at risk
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/GSK692342
n=40 participants at risk
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 participants at risk
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 participants at risk
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 participants at risk
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Infections and infestations
Cavernous sinus thrombosis
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Infections and infestations
Gastroenteritis
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Infections and infestations
Viral infection
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Nervous system disorders
Partial seizures
|
2.5%
1/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Skin and subcutaneous tissue disorders
Stevens-johnson syndrome
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
Other adverse events
| Measure |
HIV(+)-HA/GSK692342
n=40 participants at risk
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-HA/Placebo
n=40 participants at risk
HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/GSK692342
n=40 participants at risk
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(+)-TN/Placebo
n=40 participants at risk
HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/GSK692342
n=40 participants at risk
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
HIV(-)/Placebo
n=40 participants at risk
Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
20.0%
8/40 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
17.5%
7/40 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
12.5%
5/40 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
15.0%
6/40 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
7.5%
3/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
3/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
7.5%
3/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
7.5%
3/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
General disorders
Asthenia
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
15.0%
6/40 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
General disorders
Chest pain
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Gastrointestinal disorders
Constipation
|
7.5%
3/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
3/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
17.5%
7/40 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
12.5%
5/40 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
7.5%
3/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
12.5%
5/40 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
7.5%
3/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
12.5%
5/40 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
General disorders
Fatigue
|
7.5%
3/40 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
12.5%
5/40 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Nervous system disorders
Headache
|
22.5%
9/40 • Number of events 12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
7.5%
3/40 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
12.5%
5/40 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
17.5%
7/40 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
22.5%
9/40 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
7.5%
3/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Skin and subcutaneous tissue disorders
Lipoatrophy
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
7.5%
3/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
General disorders
Malaise
|
5.0%
2/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
2/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
5/40 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
7.5%
3/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
7.5%
3/40 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
5/40 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
15.0%
6/40 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.5%
3/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
General disorders
Pain
|
40.0%
16/40 • Number of events 24 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
25.0%
10/40 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
25.0%
10/40 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
20.0%
8/40 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
25.0%
10/40 • Number of events 16 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
General disorders
Pyrexia
|
15.0%
6/40 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
17.5%
7/40 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
15.0%
6/40 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
22.5%
9/40 • Number of events 12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
7.5%
3/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
7.5%
3/40 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
General disorders
Swelling
|
12.5%
5/40 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
10.0%
4/40 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.5%
1/40 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
5.0%
2/40 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
0.00%
0/40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Year 3).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER